Trial Outcomes & Findings for Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant (NCT NCT01437709)
NCT ID: NCT01437709
Last Updated: 2025-02-28
Results Overview
of the monoclonal antibody ofatumumab alone in low risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
2 years
Results posted on
2025-02-28
Participant Flow
Participant milestones
| Measure |
Ofatumumab + Bendamustine
Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab Progressors
Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine
|
Ofatumumab
Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
3
|
3
|
|
Overall Study
COMPLETED
|
22
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Ofatumumab + Bendamustine
Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab Progressors
Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine
|
Ofatumumab
Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Pt trasnferred care
|
1
|
0
|
0
|
Baseline Characteristics
Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Ofatumumab
n=3 Participants
Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab + Bendamustine
n=24 Participants
Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab Progressors
n=3 Participants
Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
73 years
n=7 Participants
|
71 years
n=5 Participants
|
73 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Dual therapy arm not assessed
of the monoclonal antibody ofatumumab alone in low risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)
Outcome measures
| Measure |
Ofatumumab
n=3 Participants
Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab + Bendamustine
Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab Progressors
Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine
|
|---|---|---|---|
|
Single Agent Efficacy (as Determined by Response Rate)
Complete Response
|
1 Participants
|
—
|
—
|
|
Single Agent Efficacy (as Determined by Response Rate)
No Response
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Single therapy arm not assessed
in high risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)
Outcome measures
| Measure |
Ofatumumab
Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab + Bendamustine
n=24 Participants
Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab Progressors
n=3 Participants
Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine
|
|---|---|---|---|
|
the Efficacy (as Determined by Response Rate) of the Combination Ofatumumab + Bendamustine
Complete Response
|
—
|
16 Participants
|
2 Participants
|
|
the Efficacy (as Determined by Response Rate) of the Combination Ofatumumab + Bendamustine
No Response
|
—
|
8 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Participants in Ofatumab Progressors group were included in overall survival calculations for both ofatumumab single-agent and ofatumumab + bendamustine chemotherapy groups because this group consists of participants who were originally assigned to the single treatment arm who then progressed and then received dual therapy treatment.
will be analyzed using Kaplan-Meier estimation, and logrank tests or Cox regression models when covariates are involved.
Outcome measures
| Measure |
Ofatumumab
n=3 Participants
Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab + Bendamustine
n=24 Participants
Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab Progressors
Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine
|
|---|---|---|---|
|
Overall Survival (OS)
|
2.2 years
Interval 0.25 to 4.8
|
5.8 years
Interval 5.8 to
Not Reached
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants in Ofatumab Progressors group were included in overall survival calculations for both ofatumumab single-agent and ofatumumab + bendamustine chemotherapy groups because this group consists of participants who were originally assigned to the single treatment arm who then progressed and then received dual therapy treatment.
will be analyzed using Kaplan-Meier estimation, and logrank tests or Cox regression models when covariates are involved.
Outcome measures
| Measure |
Ofatumumab
n=3 Participants
Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab + Bendamustine
n=24 Participants
Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab Progressors
Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
0.31 years
Interval 0.28 to
Not Reached
|
2.0 years
Interval 1.5 to 4.8
|
—
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Only participants considered responders were assessed
(calculated from confirmation of CR to progression)will be analyzed using competing risks tools (with death as a competing risk for progression), and will be done on the subsets of patients who have CR or CR/PR.
Outcome measures
| Measure |
Ofatumumab
n=1 Participants
Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab + Bendamustine
n=16 Participants
Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab Progressors
n=2 Participants
Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine
|
|---|---|---|---|
|
Remission Duration
|
3.36 years
Only 1 participant fulfilled the criteria for outcome measure 5
|
1.46 years
Interval 0.11 to 5.66
|
2.45 years
Interval 1.91 to 2.98
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: Only participants considered responders were assessed.
(calculated from confirmation of response (CR/PR) to progression. will be analyzed using competing risks tools (with death as a competing risk for progression), and will be done on the subsets of patients who have CR or CR/PR.
Outcome measures
| Measure |
Ofatumumab
n=1 Participants
Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab + Bendamustine
n=16 Participants
Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab Progressors
n=2 Participants
Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine
|
|---|---|---|---|
|
Response Duration
|
4.19 years
Only 1 participant fulfilled the criteria for outcome measure 6
|
1.67 years
Interval 0.36 to 5.93
|
2.79 years
Interval 2.2 to 3.37
|
Adverse Events
Ofatumumab
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Ofatumumab + Bendamustine
Serious events: 7 serious events
Other events: 23 other events
Deaths: 13 deaths
Ofatumumab Progressors
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Ofatumumab
n=3 participants at risk
Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab + Bendamustine
n=24 participants at risk
Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab Progressors
n=3 participants at risk
Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 6 years
|
4.2%
1/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • 6 years
|
4.2%
1/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 6 years
|
4.2%
1/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • 6 years
|
4.2%
1/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
General disorders
Fever
|
0.00%
0/3 • 6 years
|
4.2%
1/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Infections and infestations
Infection, NOS
|
0.00%
0/3 • 6 years
|
4.2%
1/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 6 years
|
4.2%
1/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • 6 years
|
4.2%
1/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • 6 years
|
4.2%
1/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • 6 years
|
4.2%
1/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • 6 years
|
4.2%
1/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm, NOS
|
0.00%
0/3 • 6 years
|
0.00%
0/24 • 6 years
|
33.3%
1/3 • 6 years
|
Other adverse events
| Measure |
Ofatumumab
n=3 participants at risk
Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab + Bendamustine
n=24 participants at risk
Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older.
|
Ofatumumab Progressors
n=3 participants at risk
Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine
|
|---|---|---|---|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • 6 years
|
8.3%
2/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
33.3%
1/3 • 6 years
|
0.00%
0/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 6 years
|
45.8%
11/24 • 6 years
|
33.3%
1/3 • 6 years
|
|
General disorders
Fatigue
|
0.00%
0/3 • 6 years
|
41.7%
10/24 • 6 years
|
100.0%
3/3 • 6 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • 6 years
|
41.7%
10/24 • 6 years
|
100.0%
3/3 • 6 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • 6 years
|
41.7%
10/24 • 6 years
|
33.3%
1/3 • 6 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • 6 years
|
41.7%
10/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 6 years
|
25.0%
6/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 6 years
|
20.8%
5/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
General disorders
Fever
|
0.00%
0/3 • 6 years
|
20.8%
5/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • 6 years
|
16.7%
4/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 6 years
|
16.7%
4/24 • 6 years
|
33.3%
1/3 • 6 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 6 years
|
16.7%
4/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 6 years
|
12.5%
3/24 • 6 years
|
66.7%
2/3 • 6 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/3 • 6 years
|
12.5%
3/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • 6 years
|
12.5%
3/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 6 years
|
8.3%
2/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 6 years
|
8.3%
2/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • 6 years
|
8.3%
2/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
General disorders
Chills
|
0.00%
0/3 • 6 years
|
8.3%
2/24 • 6 years
|
33.3%
1/3 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 6 years
|
8.3%
2/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 6 years
|
8.3%
2/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • 6 years
|
8.3%
2/24 • 6 years
|
33.3%
1/3 • 6 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • 6 years
|
8.3%
2/24 • 6 years
|
0.00%
0/3 • 6 years
|
|
General disorders
Edema limbs
|
0.00%
0/3 • 6 years
|
0.00%
0/24 • 6 years
|
33.3%
1/3 • 6 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 6 years
|
0.00%
0/24 • 6 years
|
33.3%
1/3 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • 6 years
|
0.00%
0/24 • 6 years
|
33.3%
1/3 • 6 years
|
Additional Information
Dr. Paul Hamlin, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-1667
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place