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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

Must not have

Malabsorption syndrome or other condition that precludes enteral route of administration

Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years from study start

Awards & highlights

No Placebo-Only Group

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.

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.

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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My cancer is Cyclin D1 positive.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take medicine by mouth due to a digestive condition.

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I have been tested for hepatitis C; my PCR test is negative.

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I need to take warfarin.

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I do not have any active infections, except for nail fungus.

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I have a significant history of liver problems.

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I do not have any severe illnesses that would interfere with the study or increase my risk.

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I haven't had major surgery in the last 6 weeks, except for diagnosis or line placement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years from study start

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of complete response at completion of induction therapy with this combination

Secondary study objectives

Overall response rate

Overall survival

Progression free survival (PFS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2240

Bendamustine

2015

Completed Phase 3

~3230