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Alkylating agents

Ofatumumab + Bendamustine for Mantle Cell Lymphoma

Phase 2
Waitlist Available
Led By Paul Hamlin, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is being done to study the effects of two drugs, Ofatumumab and Bendamustine, on Mantle Cell Lymphoma.

Eligible Conditions
  • Mantle Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
single agent efficacy (as determined by response rate)
the efficacy (as determined by response rate) of the combination ofatumumab + Bendamustine
Secondary outcome measures
Overall Survival (OS)
Remission duration
Response duration
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: patients receiving Immunotherapy (This arm is closed)Experimental Treatment1 Intervention
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.
Group II: patients receiving ChemoimmunotherapyExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
FDA approved

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,766 Previous Clinical Trials
8,105,556 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,862 Total Patients Enrolled
Paul Hamlin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
201 Total Patients Enrolled
~2 spots leftby May 2025
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