Trial Outcomes & Findings for A Phase I/II, a Single Arm, Open-label Study of Ofatumumab (GSK1841157) in Patients With Previously Treated Chronic Lymphocytic Leukemia (NCT NCT01077622)
NCT ID: NCT01077622
Last Updated: 2017-05-30
Results Overview
A DLT was defined as the following toxicological findings, according to the Common Terminology Criteria for Adverse Events (AE) v3.0: any treatment-related Grade (G) \>=3 non-hematotoxic AE, occurrence of G3 infusion reaction (treatment-related AE) at the day of infusion in a participant who received pre-medication or appropriate management during infusion (glucocorticoid) (the severity of the AE must have remained as \>= G3 until the next day); and any of following: \>= G4 hematotoxic treatment-related AEs (neutropenia lasting 7 days or more, febrile neutropenia).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to Week 8
Results posted on
2017-05-30
Participant Flow
Participant milestones
| Measure |
Ofatumumab
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Ofatumumab
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Overall Study
Physician Decision
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2
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
A Phase I/II, a Single Arm, Open-label Study of Ofatumumab (GSK1841157) in Patients With Previously Treated Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Age, Continuous
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66.3 Years
STANDARD_DEVIATION 5.87 • n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian - East Asian Heritage
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1 participants
n=5 Participants
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Race/Ethnicity, Customized
Asian - Japanese Heritage
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9 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to Week 8Population: All Subjects Population: all participants who received at least one dose of investigational drug. The first 3 participants enrolled in the study were evaluated for DLT according to study design.
A DLT was defined as the following toxicological findings, according to the Common Terminology Criteria for Adverse Events (AE) v3.0: any treatment-related Grade (G) \>=3 non-hematotoxic AE, occurrence of G3 infusion reaction (treatment-related AE) at the day of infusion in a participant who received pre-medication or appropriate management during infusion (glucocorticoid) (the severity of the AE must have remained as \>= G3 until the next day); and any of following: \>= G4 hematotoxic treatment-related AEs (neutropenia lasting 7 days or more, febrile neutropenia).
Outcome measures
| Measure |
Ofatumumab
n=3 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Number of Participants With a Dose-limiting Toxicity (DLT)
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0 participants
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PRIMARY outcome
Timeframe: Up to Week 48Population: All Subjects Population
Par. were evaluated in accordance with the National Cancer Institute-sponsored Working Group. CR: no lymphadenopathy (Ly)/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils \>=1.5\*10\^9/liter (L), platelets \>100\*10\^9/L, hemoglobin \>11.0 grams/deciliter, lymphocytes (LC) \<4.0\*10\^9/L, bone marrow (BM) sample must be normocellular for age, \<30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to chronic lymphocytic leukemia but related to drug toxicity. PR: \>=50% decrease in LC, Ly, size of liver and spleen, etc. nPR: nodules in BM.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Percentage of Participants (Par.) With Objective Response (OR), Defined as Complete Remission (CR), CR Incomplete (CRi), Partial Remission (PR), and Nodular PR (nPR) as Assessed by a Safety and Evaluation Review Committee (SERC) and the Investigator
SERC
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70 Percentage of participants
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Percentage of Participants (Par.) With Objective Response (OR), Defined as Complete Remission (CR), CR Incomplete (CRi), Partial Remission (PR), and Nodular PR (nPR) as Assessed by a Safety and Evaluation Review Committee (SERC) and the Investigator
Investigator
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70 Percentage of participants
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SECONDARY outcome
Timeframe: Up to Week 48Population: All Subjects Population: only those participants who progressed or died during the study were evaluated.
PFS is defined as the time from the start of treatment to the first documented sign of progressive disease (PD) or death due to any cause (whichever occurs earlier).
Outcome measures
| Measure |
Ofatumumab
n=2 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Progression-free Survival (PFS) as Assessed by a SERC
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NA Weeks
Interval 36.1 to
Because the number of evaluable participants is small (2/10), it is not possible to estimate the median value and the upper limit of the 95% confidence interval of the median value for PFS.
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SECONDARY outcome
Timeframe: Up to Week 48Population: All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.
Duration of response is defined as the time from the first documented evidence of PR or better until the first documented sign of PD or death due to any reason in participants with PR or better.
Outcome measures
| Measure |
Ofatumumab
n=7 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Duration of Response as Assessed by a SERC
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NA Weeks
None of the seven responders progressed at the time of the analysis; thus, no data can be presented.
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SECONDARY outcome
Timeframe: Up to Week 48Population: All Subjects Population
Overall survival is defined as the time from the first infusion of investigational drug to death due to any cause.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Overall Survival
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NA Weeks
All 10 participants were alive at the time of last follow-up.
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SECONDARY outcome
Timeframe: Up to Week 48Population: All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.
Time to response is defined as the time from the first infusion of investigational drug to the first response (PR or better).
Outcome measures
| Measure |
Ofatumumab
n=7 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Time to Response as Assessed by a SERC
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8.1 Weeks
Interval 8.0 to 24.1
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SECONDARY outcome
Timeframe: Up to Week 48Population: All Subjects Population: only those participants who received CLL therapy were evaluated.
Time to next CLL therapy is defined as the time from the first infusion of investigational drug to the first administration of the next CLL treatment. CLL therapy includes anti-cancer chemotherapy, anti-cancer radiotherapy, radio-immunotherapy, and antibody therapy.
Outcome measures
| Measure |
Ofatumumab
n=2 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy as Assessed by a SERC
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NA Weeks
Because the number of evaluable participants is small (2/10), it is not possible to calculate the median value for time to next CLL therapy.
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SECONDARY outcome
Timeframe: Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Blood samples of the participants were collected for the assessment of hemoglobin.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 20, n=10
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127.8 Grams per liter (g/L)
Standard Deviation 21.81
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 24, n=10
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127.8 Grams per liter (g/L)
Standard Deviation 22.31
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 28, n=9
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126.2 Grams per liter (g/L)
Standard Deviation 21.49
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 36, n=9
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128.1 Grams per liter (g/L)
Standard Deviation 20.91
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 48, n=7
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137.1 Grams per liter (g/L)
Standard Deviation 11.01
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Day 1, n=10
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115.7 Grams per liter (g/L)
Standard Deviation 15.44
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 1, n=10
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116.0 Grams per liter (g/L)
Standard Deviation 15.46
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 2, n=10
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117.4 Grams per liter (g/L)
Standard Deviation 16.37
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 3, n=10
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117.0 Grams per liter (g/L)
Standard Deviation 18.68
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 4, n=10
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116.1 Grams per liter (g/L)
Standard Deviation 18.53
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 5, n=10
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116.4 Grams per liter (g/L)
Standard Deviation 17.83
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 6, n=10
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118.1 Grams per liter (g/L)
Standard Deviation 16.25
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 7, n=10
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118.4 Grams per liter (g/L)
Standard Deviation 20.06
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 8, n=10
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119.8 Grams per liter (g/L)
Standard Deviation 20.35
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 12, n=10
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122.6 Grams per liter (g/L)
Standard Deviation 20.55
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Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator
Week 16, n=10
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125.6 Grams per liter (g/L)
Standard Deviation 21.08
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SECONDARY outcome
Timeframe: Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Blood samples of the participants were collected for the assessment of lymphocytes.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Day 1, n=10
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42.6038 Giga (10^9) per liter (GI/L)
Standard Deviation 41.66244
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 1, n=10
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29.6861 Giga (10^9) per liter (GI/L)
Standard Deviation 33.19072
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 2, n=10
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8.2290 Giga (10^9) per liter (GI/L)
Standard Deviation 6.76264
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 3, n=10
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6.9065 Giga (10^9) per liter (GI/L)
Standard Deviation 6.81649
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 4, n=10
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4.0446 Giga (10^9) per liter (GI/L)
Standard Deviation 2.70652
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 5, n=10
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2.9535 Giga (10^9) per liter (GI/L)
Standard Deviation 1.47227
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 6, n=10
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2.8063 Giga (10^9) per liter (GI/L)
Standard Deviation 1.43681
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 7, n=10
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2.4792 Giga (10^9) per liter (GI/L)
Standard Deviation 1.20853
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 8, n=10
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2.1515 Giga (10^9) per liter (GI/L)
Standard Deviation 0.94237
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 12, n=10
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1.8058 Giga (10^9) per liter (GI/L)
Standard Deviation 0.95653
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 16, n=10
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1.9575 Giga (10^9) per liter (GI/L)
Standard Deviation 1.09880
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 20, n=10
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1.8388 Giga (10^9) per liter (GI/L)
Standard Deviation 1.22494
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 24, n=10
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1.8500 Giga (10^9) per liter (GI/L)
Standard Deviation 1.33979
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 28, n=9
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1.6405 Giga (10^9) per liter (GI/L)
Standard Deviation 1.05653
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 36, n=9
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3.5754 Giga (10^9) per liter (GI/L)
Standard Deviation 5.38456
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Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator
Week 48, n=7
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1.5099 Giga (10^9) per liter (GI/L)
Standard Deviation 0.72285
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SECONDARY outcome
Timeframe: Weeks 8, 16, 24, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Bone marrow (BM) aspiration was performed, and the bone marrow smears were prepared for the assessment of lymphocytes in the BM.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator
Week 8, n=8
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57.90 Percentage of lymphocytes in the BM
Standard Deviation 23.492
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Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator
Week 16, n=5
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38.04 Percentage of lymphocytes in the BM
Standard Deviation 14.647
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Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator
Week 24, n=7
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36.96 Percentage of lymphocytes in the BM
Standard Deviation 14.961
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Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator
Week 36, n=6
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30.00 Percentage of lymphocytes in the BM
Standard Deviation 17.030
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Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator
Week 48, n=5
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23.26 Percentage of lymphocytes in the BM
Standard Deviation 9.651
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SECONDARY outcome
Timeframe: Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Blood samples of the participants were collected for the assessment of total neutrophils.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Day 1, n=10
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4.3103 GI/L
Standard Deviation 1.91880
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 1, n=10
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3.9316 GI/L
Standard Deviation 2.37732
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 2, n=10
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3.2158 GI/L
Standard Deviation 1.62185
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 3, n=10
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2.7873 GI/L
Standard Deviation 1.16531
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 4, n=10
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2.4570 GI/L
Standard Deviation 1.22611
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 5, n=10
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2.3908 GI/L
Standard Deviation 0.99250
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 6, n=10
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2.1747 GI/L
Standard Deviation 1.00743
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 7, n=10
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2.1612 GI/L
Standard Deviation 1.22393
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 8, n=10
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2.2136 GI/L
Standard Deviation 1.22993
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 12, n=10
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1.9814 GI/L
Standard Deviation 0.90783
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 16, n=10
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1.9915 GI/L
Standard Deviation 1.00746
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 20, n=10
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2.2165 GI/L
Standard Deviation 1.29881
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 24, n=10
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2.3093 GI/L
Standard Deviation 1.18840
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 28, n=9
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2.2069 GI/L
Standard Deviation 1.57995
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 36, n=9
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2.3482 GI/L
Standard Deviation 1.04228
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Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator
Week 48, n=7
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3.0431 GI/L
Standard Deviation 1.67580
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SECONDARY outcome
Timeframe: Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Blood samples of the participants were collected for the assessment of platelets.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Day 1, n=10
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106.5 GI/L
Standard Deviation 31.69
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 1, n=10
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104.0 GI/L
Standard Deviation 45.45
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 2, n=10
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100.1 GI/L
Standard Deviation 37.21
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 3, n=10
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118.3 GI/L
Standard Deviation 40.90
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 4, n=10
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114.9 GI/L
Standard Deviation 46.26
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 5, n=10
|
111.5 GI/L
Standard Deviation 47.11
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 6, n=10
|
115.7 GI/L
Standard Deviation 49.86
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 7, n=10
|
121.4 GI/L
Standard Deviation 54.65
|
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 8, n=10
|
127.7 GI/L
Standard Deviation 64.44
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 12, n=10
|
120.1 GI/L
Standard Deviation 46.29
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 16, n=10
|
124.3 GI/L
Standard Deviation 46.00
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 20, n=10
|
134.0 GI/L
Standard Deviation 41.66
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 24, n=10
|
136.6 GI/L
Standard Deviation 44.14
|
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 28, n=9
|
128.9 GI/L
Standard Deviation 41.64
|
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 36, n=9
|
143.0 GI/L
Standard Deviation 43.19
|
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Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator
Week 48, n=7
|
130.7 GI/L
Standard Deviation 53.70
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SECONDARY outcome
Timeframe: Weeks 8, 16, 24, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
SERC assessed bone marrow infiltration with the bone marrow smears of participants provided by trial sites.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
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|---|---|
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Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC
Week 8, n=8
|
57.90 Percentage of bone marrow infiltration
Standard Deviation 23.492
|
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Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC
Week 16, n=5
|
38.04 Percentage of bone marrow infiltration
Standard Deviation 14.647
|
|
Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC
Week 24, n=7
|
36.96 Percentage of bone marrow infiltration
Standard Deviation 14.961
|
|
Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC
Week 36, n=6
|
29.13 Percentage of bone marrow infiltration
Standard Deviation 17.379
|
|
Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC
Week 48, n=5
|
23.26 Percentage of bone marrow infiltration
Standard Deviation 9.651
|
SECONDARY outcome
Timeframe: Weeks 8, 16, 24, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
SERC assessed lymphocytes based on the data provided by trial sites.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC
Week 8, n=8
|
2.0120 GI/L
Standard Deviation 1.03095
|
|
Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC
Week 16, n=6
|
1.7975 GI/L
Standard Deviation 1.05163
|
|
Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC
Week 24, n=7
|
1.8784 GI/L
Standard Deviation 1.56286
|
|
Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC
Week 36, n=6
|
2.1213 GI/L
Standard Deviation 2.65560
|
|
Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC
Week 48, n=5
|
1.6284 GI/L
Standard Deviation 0.70741
|
SECONDARY outcome
Timeframe: Weeks 8, 16, 24, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
SERC assessed lymphocytes in the bone marrow (BM) based on the data with BM smears provided by trial sites.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC
Week 8, n=8
|
57.90 percentage of lymphocytes in BM
Standard Deviation 23.492
|
|
Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC
Week 16, n=5
|
38.04 percentage of lymphocytes in BM
Standard Deviation 14.647
|
|
Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC
Week 24, n=7
|
36.96 percentage of lymphocytes in BM
Standard Deviation 14.961
|
|
Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC
Week 36, n=6
|
29.13 percentage of lymphocytes in BM
Standard Deviation 17.379
|
|
Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC
Week 48, n=5
|
23.26 percentage of lymphocytes in BM
Standard Deviation 9.651
|
SECONDARY outcome
Timeframe: Weeks 8, 16, 24, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
SERC assessed total neutrophils based on the data provided by trial sites.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC
Week 8, n=8
|
2.3159 GI/L
Standard Deviation 1.35507
|
|
Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC
Week 16, n=6
|
2.5803 GI/L
Standard Deviation 1.04075
|
|
Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC
Week 24, n=7
|
2.8706 GI/L
Standard Deviation 1.39803
|
|
Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC
Week 36, n=6
|
2.1957 GI/L
Standard Deviation 0.89898
|
|
Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC
Week 48, n=5
|
2.6242 GI/L
Standard Deviation 1.05912
|
SECONDARY outcome
Timeframe: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
CD19+ CD20+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Day 1, n=10
|
33.1140 GI/L
Standard Deviation 39.40966
|
|
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Week 1, n=9
|
19.6438 GI/L
Standard Deviation 35.81756
|
|
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Week 2, n=10
|
0.0060 GI/L
Standard Deviation 0.01151
|
|
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Week 4, n=10
|
0.0565 GI/L
Standard Deviation 0.16699
|
|
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Week 6, n=10
|
0.0022 GI/L
Standard Deviation 0.00258
|
|
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Week 8, n=9
|
0.0006 GI/L
Standard Deviation 0.00136
|
|
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Week 12, n=10
|
0.0006 GI/L
Standard Deviation 0.00116
|
|
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Week 16, n=10
|
0.0003 GI/L
Standard Deviation 0.00058
|
|
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Week 20, n=10
|
0.0005 GI/L
Standard Deviation 0.00087
|
|
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Week 24, n=10
|
0.0002 GI/L
Standard Deviation 0.00037
|
|
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Week 28, n=9
|
0.0003 GI/L
Standard Deviation 0.00093
|
|
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Week 36, n=8
|
0.2525 GI/L
Standard Deviation 0.71266
|
|
Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells
Week 48, n=7
|
0.0914 GI/L
Standard Deviation 0.10259
|
SECONDARY outcome
Timeframe: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
CD20+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Number of Peripheral Blood CD20+ CD23+ Cells
Day 1, n=10
|
19.9791 GI/L
Standard Deviation 27.06441
|
|
Number of Peripheral Blood CD20+ CD23+ Cells
Week 1, n=9
|
8.9466 GI/L
Standard Deviation 21.59662
|
|
Number of Peripheral Blood CD20+ CD23+ Cells
Week 2, n=10
|
0.0319 GI/L
Standard Deviation 0.04010
|
|
Number of Peripheral Blood CD20+ CD23+ Cells
Week 4, n=10
|
0.0685 GI/L
Standard Deviation 0.14483
|
|
Number of Peripheral Blood CD20+ CD23+ Cells
Week 6, n=10
|
0.0099 GI/L
Standard Deviation 0.01869
|
|
Number of Peripheral Blood CD20+ CD23+ Cells
Week 8, n=9
|
0.0047 GI/L
Standard Deviation 0.01131
|
|
Number of Peripheral Blood CD20+ CD23+ Cells
Week 12, n=10
|
0.0080 GI/L
Standard Deviation 0.02270
|
|
Number of Peripheral Blood CD20+ CD23+ Cells
Week 16, n=10
|
0.0111 GI/L
Standard Deviation 0.03162
|
|
Number of Peripheral Blood CD20+ CD23+ Cells
Week 20, n=10
|
0.0048 GI/L
Standard Deviation 0.01277
|
|
Number of Peripheral Blood CD20+ CD23+ Cells
Week 24, n=10
|
0.0057 GI/L
Standard Deviation 0.01553
|
|
Number of Peripheral Blood CD20+ CD23+ Cells
Week 28, n=9
|
0.0002 GI/L
Standard Deviation 0.00040
|
|
Number of Peripheral Blood CD20+ CD23+ Cells
Week 36, n=8
|
0.2147 GI/L
Standard Deviation 0.60466
|
|
Number of Peripheral Blood CD20+ CD23+ Cells
Week 48, n=7
|
0.0773 GI/L
Standard Deviation 0.09355
|
SECONDARY outcome
Timeframe: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
CD19+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Number of Peripheral Blood CD19+ CD23+ Cells
Day 1, n=10
|
23.8046 GI/L
Standard Deviation 28.66936
|
|
Number of Peripheral Blood CD19+ CD23+ Cells
Week 1, n=9
|
17.4769 GI/L
Standard Deviation 22.30923
|
|
Number of Peripheral Blood CD19+ CD23+ Cells
Week 2, n=10
|
4.6972 GI/L
Standard Deviation 6.14672
|
|
Number of Peripheral Blood CD19+ CD23+ Cells
Week 4, n=10
|
1.8230 GI/L
Standard Deviation 2.49206
|
|
Number of Peripheral Blood CD19+ CD23+ Cells
Week 6, n=10
|
0.4858 GI/L
Standard Deviation 0.55687
|
|
Number of Peripheral Blood CD19+ CD23+ Cells
Week 8, n=9
|
0.2252 GI/L
Standard Deviation 0.25765
|
|
Number of Peripheral Blood CD19+ CD23+ Cells
Week 12, n=10
|
0.2122 GI/L
Standard Deviation 0.26787
|
|
Number of Peripheral Blood CD19+ CD23+ Cells
Week 16, n=10
|
0.1961 GI/L
Standard Deviation 0.34108
|
|
Number of Peripheral Blood CD19+ CD23+ Cells
Week 20, n=10
|
0.1464 GI/L
Standard Deviation 0.33132
|
|
Number of Peripheral Blood CD19+ CD23+ Cells
Week 24, n=10
|
0.1330 GI/L
Standard Deviation 0.23961
|
|
Number of Peripheral Blood CD19+ CD23+ Cells
Week 28, n=9
|
0.1123 GI/L
Standard Deviation 0.26130
|
|
Number of Peripheral Blood CD19+ CD23+ Cells
Week 36, n=8
|
0.2687 GI/L
Standard Deviation 0.71524
|
|
Number of Peripheral Blood CD19+ CD23+ Cells
Week 48, n=7
|
0.0886 GI/L
Standard Deviation 0.11398
|
SECONDARY outcome
Timeframe: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
CD19+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Number of Peripheral Blood CD19+ CD5+ Cells
Day 1, n=10
|
36.0022 GI/L
Standard Deviation 36.64910
|
|
Number of Peripheral Blood CD19+ CD5+ Cells
Week 1, n=9
|
27.9129 GI/L
Standard Deviation 32.61649
|
|
Number of Peripheral Blood CD19+ CD5+ Cells
Week 2, n=10
|
5.4212 GI/L
Standard Deviation 6.55286
|
|
Number of Peripheral Blood CD19+ CD5+ Cells
Week 4, n=10
|
2.2158 GI/L
Standard Deviation 2.62609
|
|
Number of Peripheral Blood CD19+ CD5+ Cells
Week 6, n=10
|
0.5799 GI/L
Standard Deviation 0.63484
|
|
Number of Peripheral Blood CD19+ CD5+ Cells
Week 8, n=9
|
0.2338 GI/L
Standard Deviation 0.27058
|
|
Number of Peripheral Blood CD19+ CD5+ Cells
Week 12, n=10
|
0.2420 GI/L
Standard Deviation 0.32493
|
|
Number of Peripheral Blood CD19+ CD5+ Cells
Week 16, n=10
|
0.2425 GI/L
Standard Deviation 0.38048
|
|
Number of Peripheral Blood CD19+ CD5+ Cells
Week 20, n=10
|
0.1943 GI/L
Standard Deviation 0.38386
|
|
Number of Peripheral Blood CD19+ CD5+ Cells
Week 24, n=10
|
0.1719 GI/L
Standard Deviation 0.29401
|
|
Number of Peripheral Blood CD19+ CD5+ Cells
Week 28, n=9
|
0.1449 GI/L
Standard Deviation 0.25617
|
|
Number of Peripheral Blood CD19+ CD5+ Cells
Week 36, n=8
|
0.2858 GI/L
Standard Deviation 0.73543
|
|
Number of Peripheral Blood CD19+ CD5+ Cells
Week 48, n=7
|
0.1200 GI/L
Standard Deviation 0.14511
|
SECONDARY outcome
Timeframe: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
CD20+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Number of Peripheral Blood CD20+ CD5+ Cells
Day 1, n=10
|
32.9606 GI/L
Standard Deviation 39.50102
|
|
Number of Peripheral Blood CD20+ CD5+ Cells
Week 1, n=9
|
19.3999 GI/L
Standard Deviation 35.56146
|
|
Number of Peripheral Blood CD20+ CD5+ Cells
Week 2, n=10
|
0.0134 GI/L
Standard Deviation 0.01696
|
|
Number of Peripheral Blood CD20+ CD5+ Cells
Week 4, n=10
|
0.0493 GI/L
Standard Deviation 0.13576
|
|
Number of Peripheral Blood CD20+ CD5+ Cells
Week 6, n=10
|
0.0024 GI/L
Standard Deviation 0.00185
|
|
Number of Peripheral Blood CD20+ CD5+ Cells
Week 8, n=9
|
0.0029 GI/L
Standard Deviation 0.00136
|
|
Number of Peripheral Blood CD20+ CD5+ Cells
Week 12, n=10
|
0.0020 GI/L
Standard Deviation 0.00160
|
|
Number of Peripheral Blood CD20+ CD5+ Cells
Week 16, n=10
|
0.0062 GI/L
Standard Deviation 0.00907
|
|
Number of Peripheral Blood CD20+ CD5+ Cells
Week 20, n=10
|
0.0026 GI/L
Standard Deviation 0.00147
|
|
Number of Peripheral Blood CD20+ CD5+ Cells
Week 24, n=10
|
0.0036 GI/L
Standard Deviation 0.00258
|
|
Number of Peripheral Blood CD20+ CD5+ Cells
Week 28, n=9
|
0.0022 GI/L
Standard Deviation 0.00214
|
|
Number of Peripheral Blood CD20+ CD5+ Cells
Week 36, n=8
|
0.2597 GI/L
Standard Deviation 0.72781
|
|
Number of Peripheral Blood CD20+ CD5+ Cells
Week 48, n=7
|
0.0968 GI/L
Standard Deviation 0.11682
|
SECONDARY outcome
Timeframe: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
CD23+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Number of Peripheral Blood CD23+ CD5+ Cells
Day 1, n=10
|
22.7190 GI/L
Standard Deviation 25.17338
|
|
Number of Peripheral Blood CD23+ CD5+ Cells
Week 1, n=9
|
17.2018 GI/L
Standard Deviation 21.23454
|
|
Number of Peripheral Blood CD23+ CD5+ Cells
Week 2, n=10
|
4.5264 GI/L
Standard Deviation 6.03353
|
|
Number of Peripheral Blood CD23+ CD5+ Cells
Week 4, n=10
|
1.8255 GI/L
Standard Deviation 2.49671
|
|
Number of Peripheral Blood CD23+ CD5+ Cells
Week 6, n=10
|
0.4714 GI/L
Standard Deviation 0.50306
|
|
Number of Peripheral Blood CD23+ CD5+ Cells
Week 8, n=9
|
0.2095 GI/L
Standard Deviation 0.23907
|
|
Number of Peripheral Blood CD23+ CD5+ Cells
Week 12, n=10
|
0.2114 GI/L
Standard Deviation 0.27306
|
|
Number of Peripheral Blood CD23+ CD5+ Cells
Week 16, n=10
|
0.1866 GI/L
Standard Deviation 0.34514
|
|
Number of Peripheral Blood CD23+ CD5+ Cells
Week 20, n=10
|
0.1478 GI/L
Standard Deviation 0.32088
|
|
Number of Peripheral Blood CD23+ CD5+ Cells
Week 24, n=10
|
0.1327 GI/L
Standard Deviation 0.23698
|
|
Number of Peripheral Blood CD23+ CD5+ Cells
Week 28, n=9
|
0.1035 GI/L
Standard Deviation 0.23789
|
|
Number of Peripheral Blood CD23+ CD5+ Cells
Week 36, n=8
|
0.2570 GI/L
Standard Deviation 0.68983
|
|
Number of Peripheral Blood CD23+ CD5+ Cells
Week 48, n=7
|
0.1062 GI/L
Standard Deviation 0.13388
|
SECONDARY outcome
Timeframe: Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Peripheral blood Ig kappa and Ig lambda were measured using flow cytometry. Abnormality of a ratio of Ig kappa and Ig lambda indicates clonality of lymphocytes. A normal range of this parameter is between 1.0 and 3.2.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Day 1, n=10
|
34.710 Ratio of Ig kappa/Ig lambda
Standard Deviation 38.2375
|
|
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Week 1, n=9
|
36.604 Ratio of Ig kappa/Ig lambda
Standard Deviation 36.9383
|
|
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Week 2, n=10
|
15.928 Ratio of Ig kappa/Ig lambda
Standard Deviation 26.5203
|
|
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Week 4, n=10
|
9.451 Ratio of Ig kappa/Ig lambda
Standard Deviation 25.1555
|
|
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Week 6, n=10
|
7.263 Ratio of Ig kappa/Ig lambda
Standard Deviation 20.3014
|
|
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Week 8, n=9
|
6.427 Ratio of Ig kappa/Ig lambda
Standard Deviation 16.7389
|
|
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Week 12, n=10
|
3.799 Ratio of Ig kappa/Ig lambda
Standard Deviation 8.8774
|
|
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Week 16, n=10
|
2.150 Ratio of Ig kappa/Ig lambda
Standard Deviation 3.8972
|
|
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Week 20, n=10
|
2.017 Ratio of Ig kappa/Ig lambda
Standard Deviation 3.8733
|
|
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Week 24, n=10
|
1.608 Ratio of Ig kappa/Ig lambda
Standard Deviation 2.6223
|
|
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Week 28, n=9
|
1.647 Ratio of Ig kappa/Ig lambda
Standard Deviation 2.3965
|
|
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Week 36, n=8
|
1.693 Ratio of Ig kappa/Ig lambda
Standard Deviation 1.8636
|
|
Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda
Week 48, n=7
|
3.368 Ratio of Ig kappa/Ig lambda
Standard Deviation 5.2575
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Night sweats are one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had night sweats at BL, and still had night sweats at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had night sweats at BL, but did not have night sweats at Week 1 are represented in the BL, yes; Week 1, no category.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 1, yes; n=10
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 1, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 1, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 1, no; n=10
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 2, yes; n=10
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 2, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 2, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 2, no; n=10
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 3, yes; n=10
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 3, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 3, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 3, no; n=10
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 4, yes; n=10
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 4, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 4, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 4, no; n=10
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 5, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 5, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 5, yes; n=10
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 5, no; n=10
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 6, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 6, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 6, yes; n=10
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 6, no; n=10
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 7, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 7, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 7, yes; n=10
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 7, no; n=10
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 8, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 8, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 8, yes; n=10
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 8, no; n=10
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 12, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 12, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 12, yes; n=10
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 12, no; n=10
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 16, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 16, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 16, yes; n=10
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 16, no; n=10
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 20, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 20, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 20, yes; n=10
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 20, no; n=10
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 24, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 24, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 24, yes; n=10
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 24, no; n=10
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 28, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 28, no; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 28, yes; n=9
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 28, no; n=9
|
8 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 36, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 36, no; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 36, yes; n=9
|
1 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 36, no; n=9
|
8 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 48, yes; n=7
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, yes; Week 48, no; n=7
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 48, yes; n=7
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks
BL, no; Week 48, no; n=7
|
7 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Weight loss is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had weight loss at BL, and still had weight loss at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had weight loss at BL, but did not have weight loss at Week 1 are represented in the BL, yes; Week 1, no category.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 1, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 1, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 1, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 1, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 2, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 2, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 2, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 2, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 3, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 3, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 3, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 3, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 4, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 4, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 4, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 4, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 5, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 5, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 5, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 5, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 6, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 6, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 6, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 6, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 7, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 7, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 7, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 7, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 8, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 8, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 8, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 8, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 12, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 12, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 12, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 12, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 16, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 16, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 16, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 16, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 20, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 20, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 20, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 20, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 24, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 24, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 24, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 24, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 28, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 28, no; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 28, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 28, no; n=9
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 36, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 36, no; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 36, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 36, no; n=9
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 48, yes; n=7
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, yes; Week 48, no; n=7
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 48, yes; n=7
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks
BL, no; Week 48, no; n=7
|
7 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Fever is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had fever at BL, and still had fever at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had fever at BL, but did not have fever at Week 1 are represented in the BL, yes; Week 1, no category.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 48, yes; n=7
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 48, no; n=7
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 48, yes; n=7
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 48, no; n=7
|
7 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 1, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 1, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 1, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 1, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 2, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 2, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 2, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 2, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 3, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 3, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 5, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 3, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 3, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 4, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 4, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 4, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 4, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 5, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 5, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 5, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 6, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 6, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 6, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 6, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 7, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 7, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 7, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 7, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 8, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 8, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 8, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 8, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 12, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 12, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 12, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 12, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 16, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 16, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 16, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 16, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 20, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 20, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 20, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 20, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 24, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 24, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 24, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 24, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 28, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 28, no; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 28, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 28, no; n=9
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 36, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, yes; Week 36, no; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 36, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks
BL, no; Week 36, no; n=9
|
9 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Extreme fatigue is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had extreme fatigue at BL, and still had extreme fatigue at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had extreme fatigue at BL, but did not have extreme fatigue at Week 1 are represented in the BL, yes; Week 1, no category.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 1, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 1, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 1, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 1, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 2, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 2, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 2, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 2, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 3, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 3, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 3, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 3, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 4, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 4, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 4, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 4, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 5, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 5, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 5, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 5, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 6, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 6, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 6, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 6, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 7, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 7, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 7, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 7, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 8, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 8, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 8, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 8, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 12, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 12, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 12, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 12, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 16, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 16, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 16, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 16, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 20, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 20, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 20, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 20, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 24, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 24, no; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 24, yes; n=10
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 24, no; n=10
|
10 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 28, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 28, no; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 28, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 28, no; n=9
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 36, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 36, no; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 36, yes; n=9
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 36, no; n=9
|
9 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 48, yes; n=7
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, yes; Week 48, no; n=7
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 48, yes; n=7
|
0 participants
|
|
Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks
BL, no; Week 48, no; n=7
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8, 24, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48
IgA, Week 48, n=7
|
0.086 g/L
Standard Deviation 0.2889
|
|
Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48
IgA, Week 8, n=9
|
0.014 g/L
Standard Deviation 0.1337
|
|
Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48
IgA, Week 24, n=9
|
-0.023 g/L
Standard Deviation 0.0865
|
|
Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48
IgG, Week 8, n=9
|
0.647 g/L
Standard Deviation 0.9004
|
|
Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48
IgG, Week 24, n=10
|
-0.150 g/L
Standard Deviation 0.8641
|
|
Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48
IgG, Week 48, n=7
|
-0.587 g/L
Standard Deviation 0.9680
|
|
Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48
IgM, Week 8, n=7
|
-0.063 g/L
Standard Deviation 0.1482
|
|
Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48
IgM, Week 24, n=8
|
-0.058 g/L
Standard Deviation 0.1831
|
|
Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48
IgM, Week 48, n=5
|
-0.108 g/L
Standard Deviation 0.1809
|
SECONDARY outcome
Timeframe: Screening; Weeks 24 and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
HAHA are indicators of immunogenicity to ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48
Positive at Screening, n=10
|
0 participants
|
|
Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48
Negative at Screening, n=10
|
10 participants
|
|
Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48
Positive at Week 24, n=10
|
0 participants
|
|
Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48
Negative at Week 24, n=10
|
10 participants
|
|
Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48
Positive at Week 48, n=7
|
0 participants
|
|
Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48
Negative at Week 48, n=7
|
7 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
ECOG PS is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. The grades for the scale range from 0 (fully active) to 4 (completely disabled), with increasing severity.
Outcome measures
| Measure |
Ofatumumab
n=10 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 16, deteriorated; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 1, improved; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 1, deteriorated; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 2, improved; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 2, deteriorated; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 3, improved; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 3, deteriorated; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 4, improved; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 4, deteriorated; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 5, improved; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 5, deteriorated; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 6, improved; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 6, deteriorated; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 7, improved; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 7, deteriorated; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 8, improved; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 8, deteriorated; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 12, improved; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 12, deteriorated; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 16, improved; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 20, improved; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 20, deteriorated; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 24, improved; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 24, deteriorated; n=10
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 28, improved; n=9
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 28, deteriorated; n=9
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 36, improved; n=9
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 36, deteriorated; n=9
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 48, improved; n=7
|
0 participants
|
|
Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Week 48, deteriorated; n=7
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1; Weeks 7 and 24Population: PK Parameter Population: all participants who received at least one dose of investigational drug, and in whom PK data were available and allowed parameter estimations. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Blood sampling on Day 1 and at Weeks 7 and 24 for pharmacokinetic (PK) evaluation was performed at the following time points: 0.5 hour (hr) before infusion; end of infusion; and 10 minutes (min), 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab
Day 1, n=8
|
69.33 Micrograms per milliliter (mcg/mL)
Interval 43.15 to 111.39
|
|
Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab
Week 7, n=8
|
1670.36 Micrograms per milliliter (mcg/mL)
Interval 1324.95 to 2105.81
|
|
Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab
Week 24, n=7
|
864.93 Micrograms per milliliter (mcg/mL)
Interval 658.73 to 1135.69
|
SECONDARY outcome
Timeframe: Weeks 7 and 24Population: PK Parameter Population
Blood sampling at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Minimum Plasma Concentration (Cmin) of Ofatumumab
Week 7
|
832.17 mcg/mL
Interval 539.95 to 1282.55
|
|
Minimum Plasma Concentration (Cmin) of Ofatumumab
Week 24
|
122.08 mcg/mL
Interval 28.75 to 518.37
|
SECONDARY outcome
Timeframe: Day 1; Weeks 7 and 24Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Time to Reach Cmax (Tmax) Following Ofatumumab Administration
Day 1, n=8
|
7.208 hr
Interval 6.0 to 16.5
|
|
Time to Reach Cmax (Tmax) Following Ofatumumab Administration
Week 7, n=8
|
5.225 hr
Interval 4.47 to 6.3
|
|
Time to Reach Cmax (Tmax) Following Ofatumumab Administration
Week 24, n=7
|
5.250 hr
Interval 4.0 to 28.65
|
SECONDARY outcome
Timeframe: Day 1; Weeks 7 and 24Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
t1/2 of ofatumumab is the time required for the plasma concentration of ofatumumab to decrease by half. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Half-life (t1/2) of Ofatumumab
Day 1, n=8
|
9.585 hr
Interval 5.039 to 18.232
|
|
Half-life (t1/2) of Ofatumumab
Week 7, n=8
|
331.275 hr
Interval 223.561 to 490.886
|
|
Half-life (t1/2) of Ofatumumab
Week 24, n=7
|
300.354 hr
Interval 182.417 to 494.539
|
SECONDARY outcome
Timeframe: Day 1; Weeks 7 and 24Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
AUC(0-t) was evaluated from the plasma concentration versus time curve from time zero to the last measurable time point (time t). Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab
Day 1, n=8
|
1345.1 hr*mcg/mL
Interval 466.0 to 3882.6
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab
Week 7, n=8
|
587711.3 hr*mcg/mL
Interval 332243.3 to 1039613.6
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab
Week 24, n=7
|
283751.4 hr*mcg/mL
Interval 106203.6 to 758118.2
|
SECONDARY outcome
Timeframe: Week 7Population: PK Parameter Population
Blood sampling at Week 7 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to 168 hr (AUC[0-168]) for Ofatumumab at Week 7
|
200181.8 hr*mcg/mL
Interval 139285.0 to 287703.4
|
SECONDARY outcome
Timeframe: Week 24Population: PK Parameter Population. Only participants contributing evaluable data at the indicated time points were analyzed.
Blood sampling at Week 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=7 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to 672 hr (AUC[0-672]) for Ofatumumab at Week 24
|
216678.1 hr*mcg/mL
Interval 114237.9 to 410979.2
|
SECONDARY outcome
Timeframe: Day 1; Weeks 7 and 24Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab
Day 1, n=8
|
1506.3 hr*mcg/mL
Interval 594.0 to 3820.0
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab
Week 7, n=8
|
716924.6 hr*mcg/mL
Interval 374533.0 to 1372324.7
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab
Week 24, n=7
|
302326.7 hr*mcg/mL
Interval 122602.4 to 745511.3
|
SECONDARY outcome
Timeframe: Day 1; Weeks 7 and 24Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
CL of ofatumumab from plasma of participants was evaluated. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Clearance (CL) of Ofatumumab From Plasma
Day 1, n=8
|
199.157 mL/hr
Interval 78.535 to 505.042
|
|
Clearance (CL) of Ofatumumab From Plasma
Week 7, n=8
|
9.991 mL/hr
Interval 6.952 to 14.359
|
|
Clearance (CL) of Ofatumumab From Plasma
Week 24, n=7
|
9.230 mL/hr
Interval 4.866 to 17.507
|
SECONDARY outcome
Timeframe: Day 1; Weeks 7 and 24Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab
Day 1, n=8
|
2754.1 mL
Interval 1919.2 to 3952.2
|
|
Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab
Week 7, n=8
|
4774.9 mL
Interval 3610.7 to 6314.5
|
|
Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab
Week 24, n=7
|
3999.7 mL
Interval 2903.1 to 5510.4
|
SECONDARY outcome
Timeframe: Day 1; Weeks 7 and 24Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
Vss for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body in equilibrium conditions to steady-state plasma concentrations. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Volume of Distribution at Steady State (Vss) for Ofatumumab
Day 1, n=8
|
3667.9 mL
Interval 2324.6 to 5787.5
|
|
Volume of Distribution at Steady State (Vss) for Ofatumumab
Week 7, n=8
|
1333.8 mL
Interval 928.7 to 1915.4
|
|
Volume of Distribution at Steady State (Vss) for Ofatumumab
Week 24, n=7
|
3069.2 mL
Interval 2122.9 to 4437.2
|
SECONDARY outcome
Timeframe: Day 1; Weeks 7 and 24Population: PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
MRTinf is the average amount of time that ofatumumab spends in the body. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Mean Residence Time (MRTinf) of Ofatumumab
Day 1, n=8
|
18.417 hr
Interval 10.437 to 32.5
|
|
Mean Residence Time (MRTinf) of Ofatumumab
Week 7, n=8
|
478.105 hr
Interval 333.067 to 686.3
|
|
Mean Residence Time (MRTinf) of Ofatumumab
Week 24, n=7
|
463.945 hr
Interval 263.535 to 816.762
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 36 and 48Population: All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.
The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it's is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation.
Outcome measures
| Measure |
Ofatumumab
n=8 Participants
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Serum Hemolytic Complement Titer at Weeks 36 and 48: CH50
Week 36, n=8
|
45.14 Kilo units per liter (KU/L)
Standard Deviation 13.643
|
|
Serum Hemolytic Complement Titer at Weeks 36 and 48: CH50
Week 48, n=7
|
53.70 Kilo units per liter (KU/L)
Standard Deviation 11.818
|
Adverse Events
Ofatumumab
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ofatumumab
n=10 participants at risk
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Gastrointestinal disorders
Enteritis
|
10.0%
1/10
|
Other adverse events
| Measure |
Ofatumumab
n=10 participants at risk
Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
4/10
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.0%
3/10
|
|
Blood and lymphatic system disorders
Lymphopenia
|
30.0%
3/10
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
2/10
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
2/10
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
10.0%
1/10
|
|
Blood and lymphatic system disorders
Lymph node pain
|
10.0%
1/10
|
|
Investigations
Blood lactate dehydrogenase increased
|
50.0%
5/10
|
|
Investigations
Lymphocyte count decreased
|
30.0%
3/10
|
|
Investigations
White blood cell count decreased
|
30.0%
3/10
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
2/10
|
|
Investigations
Blood glucose increased
|
20.0%
2/10
|
|
Investigations
Neutrophil count decreased
|
20.0%
2/10
|
|
Investigations
Platelet count decreased
|
20.0%
2/10
|
|
Investigations
Protein total decreased
|
20.0%
2/10
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10
|
|
Investigations
Blood albumin decreased
|
10.0%
1/10
|
|
Investigations
Blood potassium decreased
|
10.0%
1/10
|
|
Investigations
Blood potassium increased
|
10.0%
1/10
|
|
Investigations
Blood urea increased
|
10.0%
1/10
|
|
Investigations
Blood uric acid increased
|
10.0%
1/10
|
|
Investigations
Electrocardiogram QT prolonged
|
10.0%
1/10
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
1/10
|
|
Investigations
Weight increased
|
10.0%
1/10
|
|
Infections and infestations
Nasopharyngitis
|
30.0%
3/10
|
|
Infections and infestations
Herpes zoster
|
20.0%
2/10
|
|
Infections and infestations
Influenza
|
20.0%
2/10
|
|
Infections and infestations
Gastroenteritis
|
10.0%
1/10
|
|
Infections and infestations
Oral herpes
|
10.0%
1/10
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
5/10
|
|
Skin and subcutaneous tissue disorders
Eczema
|
20.0%
2/10
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
10.0%
1/10
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
30.0%
3/10
|
|
Nervous system disorders
Burning sensation
|
10.0%
1/10
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10
|
|
Nervous system disorders
Dysaesthesia
|
10.0%
1/10
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10
|
|
Nervous system disorders
Headache
|
10.0%
1/10
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
1/10
|
|
Nervous system disorders
Tremor
|
10.0%
1/10
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
40.0%
4/10
|
|
Injury, poisoning and procedural complications
Procedural complication
|
10.0%
1/10
|
|
Injury, poisoning and procedural complications
Thermal burn
|
10.0%
1/10
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
2/10
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
10.0%
1/10
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
10.0%
1/10
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
10.0%
1/10
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
2/10
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
2/10
|
|
Gastrointestinal disorders
Abdominal pain lower
|
10.0%
1/10
|
|
Gastrointestinal disorders
Colonic polyp
|
10.0%
1/10
|
|
Gastrointestinal disorders
Gastric ulcer
|
10.0%
1/10
|
|
Gastrointestinal disorders
Gastritis atrophic
|
10.0%
1/10
|
|
Gastrointestinal disorders
Gingival swelling
|
10.0%
1/10
|
|
General disorders
Fatigue
|
20.0%
2/10
|
|
General disorders
Pyrexia
|
20.0%
2/10
|
|
General disorders
Asthenia
|
10.0%
1/10
|
|
General disorders
Chills
|
10.0%
1/10
|
|
General disorders
Influenza like illness
|
10.0%
1/10
|
|
General disorders
Mucosal erosion
|
10.0%
1/10
|
|
General disorders
Oedema peripheral
|
10.0%
1/10
|
|
Ear and labyrinth disorders
Vertigo positional
|
20.0%
2/10
|
|
Ear and labyrinth disorders
Ear pain
|
10.0%
1/10
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10
|
|
Renal and urinary disorders
Dysuria
|
10.0%
1/10
|
|
Renal and urinary disorders
Pollakiuria
|
10.0%
1/10
|
|
Renal and urinary disorders
Renal impairment
|
10.0%
1/10
|
|
Eye disorders
Cataract
|
10.0%
1/10
|
|
Eye disorders
Conjunctivitis allergic
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10
|
|
Cardiac disorders
Ventricular extrasystoles
|
10.0%
1/10
|
|
Cardiac disorders
Ventricular tachycardia
|
10.0%
1/10
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
10.0%
1/10
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
10.0%
1/10
|
|
Vascular disorders
Hypotension
|
10.0%
1/10
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER