A Phase 2 interventional study of Ofatumumab (This arm is closed) and Ofatumumab + Bendamustine in Mantle Cell Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
This study is being done to understand how to treat Mantle Cell Lymphoma (MCL). The goals of treatment are to control the lymphoma with the least amount of side effects. In many cases, MCL is treated with an antibody plus chemotherapy. An antibody is a laboratory-produced substance created to attach to proteins on the cancer cells, eventually destroying them. Chemotherapy is medicine that specifically destroys cancer cells.
The purpose of this study is to find out what effects, good and/or bad, the drugs Ofatumumab and Bendamustine have on this type of cancer. Patients in this study will either receive Ofatumumab alone, or Ofatumumab combined with Bendamustine.
810 studies on the registry are indexed under Lymphoma, Mantle-Cell; 149 are open to participants now.
This study's enrollment of 30 is below the median of 39 across 718 interventional studies indexed under Lymphoma, Mantle-Cell.
Browse Lymphoma, Mantle-Cell studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,957 studies on the registry; 323 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 68 (52%) have results posted.
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The proposed study is a Simon 2 stage optimal study design investigating the activity of ofatumumab alone or in conjunction with Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older. The study design will allow for an estimation of the single agent response of ofatumumab in patients at low biologic risk for immediate disease progression.
Biological: Ofatumumab (This arm is closed)
The proposed study is a Simon 2 stage optimal study design investigating the activity of ofatumumab alone or in conjunction with Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older. The combined regimen will assess the response rates of the combined chemo- immunotherapy program in patients with need for cytoreductive therapy, or high risk for disease progression. Patients with a leukemic phase only presentation of mantle cell lymphoma generally have clinically low-risk disease, regardless of mantle cell IPI calculations. Upon reciew with the principal investigator, these patients may be stratified to the immunotherapy only arm if clinically appropriate.
Other: Ofatumumab + Bendamustine
Ofatumumab Day 1 Week 1: 1000 mg, Day 2 week 1: 1000mg. Patients who exhibit a baseline leukocytosis ≥ 20,000 will receive 300 mg of ofatumumab on day 1, week 1. Thereafter, they can receive the 1000 mg dose Ofatumumab Day 1, Weeks 2-4: 1000 mg Will reassess 8-10 weeks after conclusion of treatment with CT CAP, and following this q 12 wks for 2 yrs, then q 6mo until POD or for a maximum of 5 years
Ofatumumab day 1 + Bendamustine 90 mg/m2 days 1 \& 2 x 6 cycles q 28 days Cycle 1, day 1: Ofatumumab 1000 mg followed by Bendamustine 90 mg/m2. Patients who exhibit a leukocytosis ≥ 20,000 will receive 300 mg of ofatumumab on day 1, week 1. Thereafter, they can receive the 1000 mg dose. Cycle 1, day 2: Ofatumumab 1000mg followed by Bendamustine 90 mg/m2 Cycles 2-6: Ofatumumab 1000 mg day 1, Bendamustine 90 mg/m2 days 1 and 2 Will reassess 4-6 weeks after conclusion of treatment with CT CAP, and following this q 12 wks for 2 yrs, then q 6mo until POD or for a maximum of 5 years
Single Agent Efficacy (as Determined by Response Rate)
of the monoclonal antibody ofatumumab alone in low risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)
Time frame: 2 years
the Efficacy (as Determined by Response Rate) of the Combination Ofatumumab + Bendamustine
in high risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)
Time frame: 2 years
Overall Survival (OS)
will be analyzed using Kaplan-Meier estimation, and logrank tests or Cox regression models when covariates are involved.
Time frame: Up to 6 years
Progression Free Survival (PFS)
will be analyzed using Kaplan-Meier estimation, and logrank tests or Cox regression models when covariates are involved.
Time frame: 2 years
Remission Duration
(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.
Time frame: Up to 6 years
Response Duration
(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.
Time frame: Up to 6 years
| Milestone | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors |
|---|---|---|---|
| Started | 3 | 24 | 3 |
| Completed | 3 | 22 | 3 |
| Not completed | 0 | 2 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Pt trasnferred care | 0 | 1 | 0 |
of the monoclonal antibody ofatumumab alone in low risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)
| Participants | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors |
|---|---|---|---|
| Complete Response | 1 | — | — |
| No Response | 2 | — | — |
in high risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)
| Participants | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors |
|---|---|---|---|
| Complete Response | — | 16 | 2 |
| No Response | — | 8 | 1 |
will be analyzed using Kaplan-Meier estimation, and logrank tests or Cox regression models when covariates are involved.
| years | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors |
|---|---|---|---|
| Overall Survival (OS) | 2.2 (0.25 to 4.8) | 5.8 (5.8 to NA) | — |
will be analyzed using Kaplan-Meier estimation, and logrank tests or Cox regression models when covariates are involved.
| years | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors |
|---|---|---|---|
| Progression Free Survival (PFS) | 0.31 (0.28 to NA) | 2.0 (1.5 to 4.8) | — |
(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.
| years | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors |
|---|---|---|---|
| Remission Duration | 3.36 (NA to NA) | 1.46 (0.11 to 5.66) | 2.45 (1.91 to 2.98) |
(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.
| years | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors |
|---|---|---|---|
| Response Duration | 4.19 (NA to NA) | 1.67 (0.36 to 5.93) | 2.79 (2.20 to 3.37) |
Collected over 6 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ofatumumab | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) |
| Ofatumumab + Bendamustine | 13/24 (54.2%) | 7/24 (29.2%) | 23/24 (95.8%) |
| Ofatumumab Progressors | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) |
| Event | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors |
|---|---|---|---|
| Malignant neoplasm, NOSNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/3 | 0/24 | 1/3 |
| AnorexiaMetabolism and nutrition disorders | 0/3 | 1/24 | 0/3 |
| ConfusionPsychiatric disorders | 0/3 | 1/24 | 0/3 |
| DizzinessNervous system disorders | 0/3 | 1/24 | 0/3 |
| FallInjury, poisoning and procedural complications | 0/3 | 1/24 | 0/3 |
| FeverGeneral disorders | 0/3 | 1/24 | 0/3 |
| Infection, NOSInfections and infestations | 0/3 | 1/24 | 0/3 |
| Urinary tract infectionInfections and infestations | 0/3 | 1/24 | 0/3 |
| Infusion related reactionInjury, poisoning and procedural complications | 0/3 | 1/24 | 0/3 |
| Lung infectionInfections and infestations | 0/3 | 1/24 | 0/3 |
| Event | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors |
|---|---|---|---|
| FatigueGeneral disorders | 0/3 | 10/24 | 3/3 |
| Infusion related reactionInjury, poisoning and procedural complications | 0/3 | 10/24 | 3/3 |
| ConstipationGastrointestinal disorders | 0/3 | 3/24 | 2/3 |
| Platelet count decreasedInvestigations | 0/3 | 11/24 | 1/3 |
| Lymphocyte count decreasedInvestigations | 0/3 | 10/24 | 1/3 |
| White blood cell decreasedInvestigations | 0/3 | 10/24 | 0/3 |
| Peripheral sensory neuropathyNervous system disorders | 1/3 | 2/24 | 0/3 |
| UrticariaSkin and subcutaneous tissue disorders | 1/3 | 0/24 | 0/3 |
| NauseaGastrointestinal disorders | 0/3 | 4/24 | 1/3 |
| ChillsGeneral disorders | 0/3 | 2/24 | 1/3 |
| Age, Continuous(years) | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors | Total |
|---|---|---|---|---|
| Median | 55 (46 to 75) | 73 (44 to 89) | 71 (68 to 73) | 73 (44 to 89) |
| Sex: Female, Male(Participants) | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors | Total |
|---|---|---|---|---|
| Female | 0 | 4 | 1 | 5 |
| Male | 3 | 20 | 2 | 25 |
| Ethnicity (NIH/OMB)(Participants) | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 0 | 2 |
| Not Hispanic or Latino | 3 | 20 | 3 | 26 |
| Unknown or Not Reported | 0 | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 3 | 18 | 3 | 24 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 4 | 0 | 4 |
| Region of Enrollment(Participants) | Ofatumumab | Ofatumumab + Bendamustine | Ofatumumab Progressors | Total |
|---|---|---|---|---|
| United States | 3 | 24 | 3 | 30 |
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