Trial Outcomes & Findings for Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma (NCT NCT01716208)
NCT ID: NCT01716208
Last Updated: 2021-05-11
Results Overview
Defined as complete, or partial response, and progression-free survival. Measured by National Cancer Institute - Working Group and International Workshop on Chronic Lymphocytic Leukemia
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Up to 37 months.
Results posted on
2021-05-11
Participant Flow
Participant milestones
| Measure |
Ofatumumab + Fresh Frozen Plasma
Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).
Ofatumumab + Fresh Frozen Plasma
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Ofatumumab + Fresh Frozen Plasma
n=12 Participants
Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).
Ofatumumab + Fresh Frozen Plasma
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 37 months.Defined as complete, or partial response, and progression-free survival. Measured by National Cancer Institute - Working Group and International Workshop on Chronic Lymphocytic Leukemia
Outcome measures
| Measure |
Ofatumumab + Fresh Frozen Plasma
n=12 Participants
Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).
Ofatumumab + Fresh Frozen Plasma
|
|---|---|
|
Response to Therapy
PR
|
10 Participants
|
|
Response to Therapy
CR
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to two yearsToxicities will be graded according to the NCI CTCAE v4.0.
Outcome measures
| Measure |
Ofatumumab + Fresh Frozen Plasma
n=12 Participants
Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).
Ofatumumab + Fresh Frozen Plasma
|
|---|---|
|
Number of Participants With Toxicities
Blood bilirubin increased
|
1 Participants
|
|
Number of Participants With Toxicities
Chills
|
1 Participants
|
|
Number of Participants With Toxicities
Constipation
|
1 Participants
|
|
Number of Participants With Toxicities
Cough
|
1 Participants
|
|
Number of Participants With Toxicities
Creatinine increased
|
2 Participants
|
|
Number of Participants With Toxicities
Dehydration
|
1 Participants
|
|
Number of Participants With Toxicities
Dizziness
|
2 Participants
|
|
Number of Participants With Toxicities
Dyspepsia
|
1 Participants
|
|
Number of Participants With Toxicities
Dyspnea
|
3 Participants
|
|
Number of Participants With Toxicities
Blepharitis
|
1 Participants
|
|
Number of Participants With Toxicities
Fatigue
|
5 Participants
|
|
Number of Participants With Toxicities
Flushing
|
1 Participants
|
|
Number of Participants With Toxicities
Gastroesophageal reflux disease
|
1 Participants
|
|
Number of Participants With Toxicities
Feverish
|
1 Participants
|
|
Number of Participants With Toxicities
Generalized muscle weakness
|
1 Participants
|
|
Number of Participants With Toxicities
Headache
|
4 Participants
|
|
Number of Participants With Toxicities
Hiccups
|
1 Participants
|
|
Number of Participants With Toxicities
Hyperkalemia
|
1 Participants
|
|
Number of Participants With Toxicities
Hypertension
|
2 Participants
|
|
Number of Participants With Toxicities
Hypocalcemia
|
1 Participants
|
|
Number of Participants With Toxicities
hyponatremia
|
1 Participants
|
|
Number of Participants With Toxicities
Infusion related reaction
|
7 Participants
|
|
Number of Participants With Toxicities
Insomnia
|
2 Participants
|
|
Number of Participants With Toxicities
Lung infection
|
1 Participants
|
|
Number of Participants With Toxicities
Lymph node pain
|
1 Participants
|
|
Number of Participants With Toxicities
Lymphocyte count increased
|
2 Participants
|
|
Number of Participants With Toxicities
Nausea
|
5 Participants
|
|
Number of Participants With Toxicities
Neutrophil count decreased
|
4 Participants
|
|
Number of Participants With Toxicities
Palpitations
|
1 Participants
|
|
Number of Participants With Toxicities
Paresthesia
|
1 Participants
|
|
Number of Participants With Toxicities
peripheral sensory neuropathy
|
1 Participants
|
|
Number of Participants With Toxicities
Platelet count decreased
|
4 Participants
|
|
Number of Participants With Toxicities
Rash acneiform
|
1 Participants
|
|
Number of Participants With Toxicities
Rash maculo-papular
|
1 Participants
|
|
Number of Participants With Toxicities
Aspergillus Pneumonia
|
1 Participants
|
|
Number of Participants With Toxicities
Sinus tachycardia
|
1 Participants
|
|
Number of Participants With Toxicities
Sinusitis
|
2 Participants
|
|
Number of Participants With Toxicities
Rash
|
1 Participants
|
|
Number of Participants With Toxicities
Lesions on face, neck, scalp
|
1 Participants
|
|
Number of Participants With Toxicities
Guttate Psoriasis (Exacerbation of Symptoms)
|
1 Participants
|
|
Number of Participants With Toxicities
Skin infection, Eyelid
|
4 Participants
|
|
Number of Participants With Toxicities
Upper respiratory infection
|
1 Participants
|
|
Number of Participants With Toxicities
Wheezing
|
1 Participants
|
|
Number of Participants With Toxicities
White blood cell decreased
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to two yearsCount of participants known to be alive up to two years from the time from start of treatment.
Outcome measures
| Measure |
Ofatumumab + Fresh Frozen Plasma
n=12 Participants
Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).
Ofatumumab + Fresh Frozen Plasma
|
|---|---|
|
Overall Survival
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to two weeksComplement CH50 is a blood test that helps us determine whether protein abnormalities and deficiencies in the complement system are responsible for any increase in autoimmune activity.
Outcome measures
| Measure |
Ofatumumab + Fresh Frozen Plasma
n=12 Participants
Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).
Ofatumumab + Fresh Frozen Plasma
|
|---|---|
|
Percent Reduction in Complement Levels (CH50)
|
54 Percentage change
Interval 20.0 to 100.0
|
Adverse Events
Ofatumumab + Fresh Frozen Plasma
Serious events: 2 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Ofatumumab + Fresh Frozen Plasma
n=12 participants at risk
Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).
Ofatumumab + Fresh Frozen Plasma
|
|---|---|
|
Infections and infestations
Lung infection
|
8.3%
1/12 • Number of events 1 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
1/12 • Number of events 1 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
Other adverse events
| Measure |
Ofatumumab + Fresh Frozen Plasma
n=12 participants at risk
Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint).
Ofatumumab + Fresh Frozen Plasma
|
|---|---|
|
Immune system disorders
Allergic reaction
|
33.3%
4/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
6/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
3/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Investigations
Blood bilirubin increased
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
General disorders
Chills
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Investigations
Creatinine increased
|
16.7%
2/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Gastrointestinal disorders
Dyspspsia
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
3/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Eye disorders
Blepharitis
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
General disorders
Fatigue
|
41.7%
5/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Vascular disorders
Flushing
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
General disorders
Feverish
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Nervous system disorders
Headache
|
33.3%
4/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Vascular disorders
Hypertension
|
16.7%
2/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
58.3%
7/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Psychiatric disorders
Insomnia
|
16.7%
2/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Blood and lymphatic system disorders
Lymph node pain
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Investigations
Lymphocyte count increased
|
16.7%
2/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Gastrointestinal disorders
Nausea
|
41.7%
5/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Investigations
Neutrophil count decreased
|
33.3%
4/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Nervous system disorders
Paresthesia
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Investigations
Platelet count decreased
|
33.3%
4/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Skin and subcutaneous tissue disorders
Rash acneform
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Aspergillus Pneumonia
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Infections and infestations
Sinusitis
|
16.7%
2/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Infections and infestations
Skin infection
|
33.3%
4/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Skin and subcutaneous tissue disorders
Guttate Psoriasis (Exacerbation of Symptoms)
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Investigations
White blood cell decreased
|
25.0%
3/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
8.3%
1/12 • Up to 2 years.
Incidence of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place