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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
4,751 Previous Clinical Trials
8,067,442 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,592 Total Patients Enrolled
Paul Hamlin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
201 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elaborate on any prior investigations involving the combination of Ofatumumab and Bendamustine?

"Ofatumumab + Bendamustine was first examined in 2010 at the National Institutes of Health Clinical Centre, 9000 Rockville Pike. 71 completed trials have been administered since then and there are currently 23 clinical studies being conducted that are actively recruiting participants; many of these coming from Basking Ridge, New jersey."

Answered by AI

What conditions is the Ofatumumab + Bendamustine drug regimen most commonly prescribed for?

"Ofatumumab + Bendamustine is usually prescribed for cases of multiple sclerosis. It can additionally help those who are resistant to fludarabine and alemtuzumab, cannot receive fludarabine-based therapy, or have active secondary progressive multiple sclerosis (spms)."

Answered by AI

What potential risks does the combination of Ofatumumab and Bendamustine present to patients?

"Our team at Power has assigned Ofatumumab + Bendamustine a safety score of 2, as the drug is only in Phase 2 trials and thus lacks any efficacy data."

Answered by AI

Is recruitment ongoing for this experiment?

"Unfortunately, this trial has already concluded its recruitment. Initially posted on September 1st 2011 and last edited October 3rd 2022, any interested parties have likely already joined the study. However, there are 1720 clinical trials for mantle cell lymphoma (MCL) and 23 Ofatumumab + Bendamustine studies that are still actively recruiting patients."

Answered by AI

How many volunteers have signed up for this research experiment?

"This clinical trial is currently not enrolling, however it was initially posted on September 1st 2011 and most recently updated on October 3rd 2022. If you are seeking alternative studies, there exists 1720 experimental trials looking for candidates with mantle cell lymphoma (MCL) in addition to 23 research programs that require participants taking Ofatumumab + Bendamustine."

Answered by AI

What is the expected outcome of this trial?

"The main goal of this two-year long trial is to determine the efficacy of a single drug, as determined by response rate. Secondary objectives include assessing Overall Survival using Kaplan-Meier estimation and logrank tests/Cox regression models; Progression Free Survival evaluated through the same process; and Response Duration calculated from confirmation of response (CR/PR) to progression with competing risks tools that consider death as an alternate outcome for progression in patients achieving CR or CR/PR."

Answered by AI

How many locations are currently participating in this investigation?

"6 clinical sites have been identified for this trial. These include Memorial Sloan Kettering Cancer Center at Basking Ridge in Basking Ridge, Memorial Sloan Kettering West Harrison in Harrison and Memorial Sloan Kettering Cancer Center at Mercy Medical Center in Rockville Centre, among other medical centres."

Answered by AI

Is this a fresh clinical trial?

"Research for the efficacy of Ofatumumab + Bendamustine began a decade ago, as GlaxoSmithKline sponsored its initial clinical trial in 2010. After this preliminary study, involving 32 patients, Phase 2 drug approval was granted and now 23 active trials are taking place across 290 cities spanning 45 countries."

Answered by AI
~2 spots leftby Apr 2025