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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 belowSelect...
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:Select...
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
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 moreAwards & 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
~2200
Bendamustine
2015
Completed Phase 3
~3230
Obinutuzumab
2014
Completed Phase 3
~3470
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,012,037 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,810 Previous Clinical Trials
8,159,609 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,556 Previous Clinical Trials
569,370 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lymphoma is confirmed as mantle cell type.I am a man who will use highly effective birth control and not donate sperm during and for 6 months after treatment.My cancer cells have a specific genetic marker (t(11;14)).I cannot take medicine by mouth due to a digestive condition.A specialist confirmed I have mantle cell lymphoma through a biopsy.I have been tested for hepatitis C; my PCR test is negative.I have had another type of cancer that might interfere with this study.I do not have any active infections, except for nail fungus.I have been diagnosed with mantle cell lymphoma and have not received previous therapy for it.You must use highly effective birth control methods such as female or male sterilization, hormonal contraceptives that stop ovulation or intrauterine devices (IUDs) to prevent pregnancy during the trial. Examples of effective IUDs include hormone-releasing IUDs or copper IUDs.I can take care of myself and am up and about more than half of my waking hours.I understand and commit to reliable contraception methods during the trial.I had or have hidden hepatitis B but with undetectable virus levels, and agree to monthly tests and preventive treatment.I need to take warfarin.I will use protection or abstain from sex to prevent pregnancy during and 6 months after treatment.I agree to either not have sex or use birth control, and not donate sperm.I have a significant history of liver problems.I agree to use effective birth control or remain abstinent and not donate sperm while on obinutuzumab and for 6 months after.I had skin cancer, early-stage melanoma, cervical cancer in situ, low-risk prostate or thyroid cancer, or DCIS but am now in remission.My cancer is Cyclin D1 positive.I have not received any treatment for lymphoma, except possibly steroids for urgent symptoms.I haven't had any live-virus vaccines in the last 28 days and don't need any during the study.I agree to use highly effective birth control or remain abstinent during and after treatment.I haven't taken certain strong medications or eaten grapefruit and similar fruits within a week before starting venetoclax.I do not have any severe illnesses that would interfere with the study or increase my risk.My kidney or liver problems are due to my cancer, as confirmed by my doctor.I have HIV with a CD4 count over 400, undetectable viral load, and no AIDS-defining illness.My kidney function is within the required range.I am a woman who can still have children.I haven't had major surgery in the last 6 weeks, except for diagnosis or line placement.
Research Study Groups:
This trial has the following groups:- Group 1: Venetoclax, bendamustine, obinutuzumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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