Trial Outcomes & Findings for Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia (NCT NCT01444716)
NCT ID: NCT01444716
Last Updated: 2021-07-26
Results Overview
Response = (complete response \[CR\] + partial response \[PR\]) per 2008 National Cancer Institute (NCI)-Working Group (WG) criteria. Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow. Partial Response (PR): At least 50 % reduction in disease signs/symptoms and normalization of peripheral blood.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Up to 3 years, 10 months
Results posted on
2021-07-26
Participant Flow
Participant milestones
| Measure |
Treatment (Ofatumumab)
Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
Ofatumumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Ofatumumab)
n=34 Participants
Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
Ofatumumab: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=93 Participants
|
|
Age, Continuous
|
73 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years, 10 monthsPopulation: Of the 34 participants registered, 32 were evaluable for response.
Response = (complete response \[CR\] + partial response \[PR\]) per 2008 National Cancer Institute (NCI)-Working Group (WG) criteria. Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow. Partial Response (PR): At least 50 % reduction in disease signs/symptoms and normalization of peripheral blood.
Outcome measures
| Measure |
Treatment (Ofatumumab)
n=32 Participants
Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
Ofatumumab: Given IV
|
|---|---|
|
Participants With a Response
|
23 Participants
|
SECONDARY outcome
Timeframe: Up to 3 years, 10 monthsPopulation: Of the 34 participants registered, 32 were evaluable for response.
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Outcome measures
| Measure |
Treatment (Ofatumumab)
n=32 Participants
Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
Ofatumumab: Given IV
|
|---|---|
|
Progression-free Survival (PFS)
|
21 Months
Interval 9.0 to 32.0
|
SECONDARY outcome
Timeframe: Up to 3 years, 10 monthsPopulation: Of the 34 participants registered, 32 were evaluable for response.
Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow.
Outcome measures
| Measure |
Treatment (Ofatumumab)
n=32 Participants
Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
Ofatumumab: Given IV
|
|---|---|
|
Participants With a Complete Response (CR)
|
6 Participants
|
Adverse Events
Treatment (Ofatumumab)
Serious events: 9 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Ofatumumab)
n=34 participants at risk
Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
Ofatumumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • Number of events 1 • Up to 3 years, 10 Months
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Number of events 1 • Up to 3 years, 10 Months
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Urothelial Carcinoma
|
2.9%
1/34 • Number of events 1 • Up to 3 years, 10 Months
|
|
Nervous system disorders
Transient Ichemic Attack
|
2.9%
1/34 • Number of events 1 • Up to 3 years, 10 Months
|
|
Nervous system disorders
Headache
|
2.9%
1/34 • Number of events 1 • Up to 3 years, 10 Months
|
|
Renal and urinary disorders
Hematuria
|
2.9%
1/34 • Number of events 1 • Up to 3 years, 10 Months
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
2.9%
1/34 • Number of events 1 • Up to 3 years, 10 Months
|
|
Cardiac disorders
Myocardial Infarction
|
2.9%
1/34 • Number of events 1 • Up to 3 years, 10 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
1/34 • Number of events 1 • Up to 3 years, 10 Months
|
|
Cardiac disorders
Aortic Valve Disease
|
2.9%
1/34 • Number of events 1 • Up to 3 years, 10 Months
|
|
General disorders
Fever
|
2.9%
1/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
Infections and infestations
Lung Infection
|
2.9%
1/34 • Number of events 1 • Up to 3 years, 10 Months
|
|
Vascular disorders
Thromboembolic Event
|
2.9%
1/34 • Number of events 1 • Up to 3 years, 10 Months
|
Other adverse events
| Measure |
Treatment (Ofatumumab)
n=34 participants at risk
Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
Ofatumumab: Given IV
|
|---|---|
|
General disorders
Abdoninal Pain
|
20.6%
7/34 • Number of events 7 • Up to 3 years, 10 Months
|
|
Blood and lymphatic system disorders
Anemia
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
Injury, poisoning and procedural complications
Bone Fracture
|
11.8%
4/34 • Number of events 4 • Up to 3 years, 10 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
Gastrointestinal disorders
Diarrhea
|
14.7%
5/34 • Number of events 5 • Up to 3 years, 10 Months
|
|
Nervous system disorders
Dizziness
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
General disorders
edema
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
General disorders
Fatigue
|
14.7%
5/34 • Number of events 5 • Up to 3 years, 10 Months
|
|
General disorders
Fever
|
17.6%
6/34 • Number of events 6 • Up to 3 years, 10 Months
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.8%
3/34 • Number of events 3 • Up to 3 years, 10 Months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.8%
3/34 • Number of events 3 • Up to 3 years, 10 Months
|
|
General disorders
Infusion Related Reaction
|
52.9%
18/34 • Number of events 19 • Up to 3 years, 10 Months
|
|
Gastrointestinal disorders
Mucositis
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
Gastrointestinal disorders
Nausea
|
8.8%
3/34 • Number of events 3 • Up to 3 years, 10 Months
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other Neoplasm
|
8.8%
3/34 • Number of events 3 • Up to 3 years, 10 Months
|
|
General disorders
Pain
|
20.6%
7/34 • Number of events 7 • Up to 3 years, 10 Months
|
|
Cardiac disorders
Palpitations
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
Nervous system disorders
Paresthesia
|
8.8%
3/34 • Number of events 3 • Up to 3 years, 10 Months
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.8%
4/34 • Number of events 4 • Up to 3 years, 10 Months
|
|
Infections and infestations
Infections
|
17.6%
6/34 • Number of events 7 • Up to 3 years, 10 Months
|
|
Infections and infestations
Skin Infection
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
Infections and infestations
Sinusitis
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
|
Infections and infestations
Upper Respiratory Infection
|
20.6%
7/34 • Number of events 7 • Up to 3 years, 10 Months
|
|
Infections and infestations
Urinary Tract Infection
|
17.6%
6/34 • Number of events 6 • Up to 3 years, 10 Months
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.9%
2/34 • Number of events 2 • Up to 3 years, 10 Months
|
Additional Information
Allessandra Ferrajoli, MD./Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-792-2063
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place