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Anti-tumor antibiotic

Triple Drug Therapy for Mantle Cell Lymphoma

Phase 2
Waitlist Available
Led By Jonathon B. Cohen, MD, MS
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fluorescent in situ hybridization (FISH) or conventional cytogenetics positive for t(11;14)
Documentation by a hematopathologist at the treating institution that there is pathologic evidence of mantle cell lymphoma if neither criteria above are met
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years from study start
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat mantle cell lymphoma, a cancer of the lymph nodes. The drugs work in different ways to kill cancer cells or stop their growth.

Who is the study for?
This trial is for adults with untreated Mantle Cell Lymphoma. Participants must be in good physical condition (ECOG 0-2), have adequate blood counts and organ function, and no prior lymphoma therapy except possibly steroids. Women of childbearing potential and men must agree to effective contraception or abstinence.Check my eligibility
What is being tested?
The study tests a combination of chemotherapy drugs bendamustine and venetoclax with the immunotherapy drug obinutuzumab in treating Mantle Cell Lymphoma. It's a phase II trial aiming to see how well these drugs work together to stop cancer cell growth by killing them or stopping their spread.See study design
What are the potential side effects?
Possible side effects include reactions from the immune system, such as inflammation in various organs due to obinutuzumab, plus typical chemotherapy-related issues like nausea, fatigue, low blood counts leading to increased infection risk, liver problems, and kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer cells have a specific genetic marker (t(11;14)).
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A specialist confirmed I have mantle cell lymphoma through a biopsy.
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I can take care of myself and am up and about more than half of my waking hours.
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I understand and commit to reliable contraception methods during the trial.
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I have been diagnosed with mantle cell lymphoma and have not received previous therapy for it.
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I am a woman who can still have children.
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My kidney function is within the required range.
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I agree to use effective birth control or remain abstinent and not donate sperm while on obinutuzumab and for 6 months after.
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My cancer is Cyclin D1 positive.
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I agree to use highly effective birth control or remain abstinent during and after treatment.
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My kidney function is within the required range.
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I am a woman who can still have children.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years from study start
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years from study start for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of complete response at completion of induction therapy with this combination
Secondary outcome measures
Overall response rate
Overall survival
Progression free survival (PFS)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Venetoclax, bendamustine, obinutuzumabExperimental Treatment3 Interventions
Patients receive venetoclax PO on days 1-28 of course 1 and days 1-10 of subsequent courses, bendamustine IV on days 1 and 2, and obinutuzumab IV on days 1, 8, and 15 of course 1 and day 1 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unaccepted toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Bendamustine
2015
Completed Phase 3
~2950
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,623 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,659 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,657 Total Patients Enrolled

Media Library

Bendamustine (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03872180 — Phase 2
Mantle Cell Lymphoma Research Study Groups: Venetoclax, bendamustine, obinutuzumab
Mantle Cell Lymphoma Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT03872180 — Phase 2
Bendamustine (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03872180 — Phase 2

Frequently Asked Questions

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

Is Bendamustine a safe drug for patients to use?

"Due to Bendamustine's limited efficacy data, it was assigned a safety score of 2 out of 3."

Answered by AI

Are there any openings remaining for individuals to join this medical research?

"Clinicaltrials.gov states that this research endeavour is no longer recruiting patients, having first been posted on April 11th 2019 and last edited November 2nd 2022. However, 2063 other trials are still actively looking for study participants."

Answered by AI

What prior research has utilized Bendamustine as a therapeutic agent?

"At present, there are a total of 344 Bendamustine trials occurring around the globe. Out of these, 52 investigations are currently in their third phase and Edmonton, Alberta houses most studies involving this medication. Across 13082 distinct sites worldwide, patients can access clinical research for Bendamustine."

Answered by AI

What is the current enrollment size of this investigation?

"This particular study is no longer accepting applicants, as it was first posted on April 11th 2019 and last updated November 2nd 2022. However, if you are searching for alternative trials to apply to, there are 1,719 ccnd1 positive studies and 344 Bendamustine clinical studies that require participants."

Answered by AI

What conditions is Bendamustine usually prescribed for?

"Bendamustine is traditionally utilized to treat refractory mantle cell lymphoma, but can also be applied as a therapeutic approach for patients suffering from follicular lymphoma, chronic lympocytic leukemia, and hodgkin disease."

Answered by AI
~4 spots leftby Mar 2025