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Anti-tumor antibiotic

BR-I + Venetoclax for Mantle Cell Lymphoma

Phase < 1
Waitlist Available
Led By Anita Kumar
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
Patients who have been previously treated with ibrutinib or acalabrutinib (or any alternate BTK-inhibitor) are eligible, provided they had evidence of response (at least Stable Disease, Partial Response, or Complete Response) and did not progress within 6 months of treatment initiation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will test the safety of adding Venetoclax to the standard BR-I cancer treatment.

Who is the study for?
Adults over 18 with relapsed or refractory Mantle Cell Lymphoma who've had some treatment success with BR or Bendamustine alone, and have good organ function. They must not be pregnant, agree to contraception, and can't join if they've had certain recent treatments, infections, liver disease, stem cell transplants within specific timeframes, or are on immunosuppressants.Check my eligibility
What is being tested?
The trial is testing the safety of Venetoclax when combined with FDA-approved treatments: Bendamustine, Rituximab and Ibrutinib (BR-I). It aims to understand how Venetoclax affects patients alongside these established therapies for Mantle Cell Lymphoma.See study design
What are the potential side effects?
Potential side effects may include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems. Liver enzymes might rise indicating potential liver issues. Allergic reactions could occur due to any of the drugs involved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been treated with a medication called ibrutinib or acalabrutinib (or a similar type of medication) before, and it showed some positive effect on your condition. You did not get worse within 6 months of starting the treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose
Treatment related toxicity evaluated using CTCAE v4.0

Trial Design

1Treatment groups
Experimental Treatment
Group I: BR-I in combination with VENExperimental Treatment2 Interventions
The BR-I (bendamustine, rituximab, ibrutinib) regimen will be administered in combination with VEN (Venetoclax).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BR-I (bendamustine, rituximab, ibrutinib)
2017
Completed Early Phase 1
~10
VEN (Venetoclax)
2017
Completed Early Phase 1
~10

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,798 Total Patients Enrolled
Anita KumarPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Bendamustine (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03295240 — Phase < 1
Mantle Cell Lymphoma Research Study Groups: BR-I in combination with VEN
Mantle Cell Lymphoma Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT03295240 — Phase < 1
Bendamustine (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03295240 — Phase < 1

Frequently Asked Questions

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

Has there been any other research conducted on the combination of bendamustine, rituximab, and ibrutinib?

"Coined in 1993 by the National Institutes of Health Clinical Center located at 9000 Rockville Pike, BR-I (bendamustine, rituximab and ibrutinib) has since been trialled 991 times. At present there are 718 active trials being conducted across Montvale, New york."

Answered by AI

Are any individuals currently eligible to participate in this research trial?

"Per clinicaltrials.gov, this trial is not presently accepting any participants; it was initially posted on September 20th 2017 and the listing's last update occurred on February 3rd 2022. Although this investigation has closed its recruitment window, there are an additional 2442 other studies that may be of interest to patients seeking treatment options currently."

Answered by AI

What pathologies is BR-I (bendamustine, rituximab, ibrutinib) usually indicated for?

"BR-I (bendamustine, rituximab, ibrutinib) is predominantly prescribed to those suffering from diffuse large b-cell lymphoma. It has also been known to bring relief for hodgkin disease, b-cell lymphomas and polyangium patients."

Answered by AI

How many locations are hosting this research endeavor?

"Currently, this medical trial is being held at 7 different sites. These include Montvale and New york in Commack, as well as 5 other locations. If you choose to join the study, it might be wise to select a clinic near your residence so that travel costs are kept minimal."

Answered by AI

How many participants are currently being admitted to this trial?

"Unfortunately, no new applicants are being accepted for this trial at the moment; it was posted on 9/20/2017 and has not been updated since 2/3/2022. If you're looking for other clinical trials related to lymphoma, there is an abundance of active studies with 1724 recruiting patients in that area alone and 718 enrolling participants into BR-I (bendamustine, rituximab, ibrutinib) research."

Answered by AI
~1 spots leftby Mar 2025