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Monoclonal Antibodies
Combination Therapy for Mantle Cell Lymphoma
Phase 2
Waitlist Available
Led By Catherine S Diefenbach
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically confirmed relapsed or primary refractory mantle cell lymphoma with concurrent or prior tissue sample immunohistochemistry (IHC) positive for cyclin D1 or that is positive for fluorescence in situ hybridization (FISH) or cytogenetics for t(11;14)
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying a combination of drugs to treat mantle cell lymphoma that has come back or does not respond to treatment. The drugs are polatuzumab vedotin, venetoclax, and rituximab and hyaluronidase human.
Who is the study for?
This trial is for adults with mantle cell lymphoma that has returned or isn't responding to treatment. They must have measurable disease, be in fair health (ECOG 0-2), and have adequate blood counts and organ function. Women of childbearing potential must test negative for pregnancy and agree to contraception, as should men.Check my eligibility
What is being tested?
The trial tests a combination therapy using polatuzumab vedotin, venetoclax, and rituximab hyaluronidase against relapsed/refractory mantle cell lymphoma. It aims to see if this approach is more effective than standard treatments by targeting cancer cells more precisely.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs (infusion reactions), low blood counts leading to increased infection risk or bleeding problems, liver issues, fatigue, nausea, diarrhea, and possible allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My mantle cell lymphoma has relapsed or is not responding to treatment, and tests show specific genetic markers.
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I can care for myself and am up and about more than 50% of my waking hours.
Select...
I have a tumor that is at least 1 x 1.5 cm big.
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My mantle cell lymphoma has returned or didn't respond to treatment, and tests show specific genetic markers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response (CR) rate
Secondary outcome measures
Best response rate to maintenance therapy
Incidence of adverse events (AEs)
Overall response rate (ORR)
+2 moreOther outcome measures
High risk cytogenetic alterations
Minimal residual disease (MRD) analysis
Risk stratification scores
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (rituximab, polatuzumab vedotin, venetoclax)Experimental Treatment4 Interventions
INDUCTION: Patients receive rituximab IV on day 1 of cycle 1 and rituximab and hyaluronidase human SC over 5 minutes on day 1 of cycles 2-6. Patients also receive polatuzumab vedotin IV over 30-90 minutes on day 1 and venetoclax PO daily on days 1-21. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive venetoclax PO daily on days 1-21 and rituximab and hyaluronidase human SC over 5 minutes every 60 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,604 Total Patients Enrolled
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,073 Total Patients Enrolled
Catherine S DiefenbachPrincipal InvestigatorAcademic and Community Cancer Research United
3 Previous Clinical Trials
197 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women who are currently pregnant.You must have enough infection-fighting cells in your blood (ANC >= 1000/mm^3) within 14 days before starting the study.I haven't had radioimmunotherapy in the last 12 weeks.I agree to use highly effective birth control or abstain from sex during and after treatment.Your blood count needs to show a hemoglobin level of at least 9.0 g/dL within two weeks before enrolling in the trial.I am of childbearing age and not using birth control.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My mantle cell lymphoma has relapsed or is not responding to treatment, and tests show specific genetic markers.I have had PML in the past.I completed my stem cell transplant less than 100 days ago.I have not received a live virus vaccine in the last 28 days.I am not on any other experimental or chemotherapy treatments for my cancer.My cancer was CD20-negative at the time it worsened or came back.I agree to use effective birth control or remain abstinent and not donate sperm for 6 months after my last dose.I haven't had monoclonal antibody or ADC therapy in the last 4 weeks or 5 half-lives, whichever is longer.You have at least one visible lump or abnormality that measures at least 1 x 1.5 cm.I have had a stem cell transplant from a donor.I currently have an infection.My mantle cell lymphoma has worsened after 2 treatments or after a BTK inhibitor therapy. I may have had a stem cell transplant.I am allergic to certain cancer drugs like rituximab, polatuzumab vedotin, and venetoclax.Any major side effects from my previous treatments have improved to mild or moderate.I have had cancer before, but it was treated and is not likely to interfere with this study.I haven't had major surgery in the last 28 days and don't expect any during the study.You cannot or do not want to swallow pills.I do not have severe heart or lung conditions that could interfere with the study.I have a condition that affects how my body absorbs food.I have a specific type of low-risk lymphoma and it has come back after at least two treatments.I am on a stable dose of corticosteroids (20 mg/day or less) for at least 4 weeks.Your blood clotting ability, measured by PTT or aPTT, must not be more than 1.5 times the upper limit of normal.Your blood clotting test, called international normalized ratio, should not be more than 1.5 times the normal limit, unless you are taking anticoagulant medication. The test should have been done within 14 days before registration.I have a specific type of low-risk lymphoma and it has come back after at least two treatments.I can care for myself and am up and about more than 50% of my waking hours.You must have a minimum number of platelets in your blood, which will be checked within 14 days before starting the trial.I do not have severe numbness or pain in my hands or feet.My kidney function, measured by creatinine clearance, is good.I haven't had cancer treatments, except possibly ibrutinib, in the last 2 weeks.I haven't taken certain strong medications like fluconazole or rifampin in the last week.I had hepatitis B or C but have cleared the virus.I have had brain lymphoma or cancer spread to the lining of my brain and spinal cord.I have a significant history of liver problems.I have a history of inflammatory bowel disease or currently have active bowel inflammation.I need warfarin treatment.I have a tumor that is at least 1 x 1.5 cm big.My mantle cell lymphoma has returned or didn't respond to treatment, and tests show specific genetic markers.My mantle cell lymphoma has worsened after at least two treatments or one BTK inhibitor therapy. I may have had a stem cell transplant.I am currently breastfeeding.I am willing to give tissue samples for research.You have not eaten grapefruit, grapefruit products, Seville oranges, or star fruit in the past 3 days before enrolling in the study.My previous cancer has been in remission for 3 years or less without treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (rituximab, polatuzumab vedotin, venetoclax)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the precedent for Rituximab's efficacy?
"Rituximab is being trialed in 130 Phase 3 clinical trials, 656 studies in total. The medication is being tested at 24017 locations worldwide, with the majority of these sites based in Edmonton, Alberta."
Answered by AI
How many people are allowed to participate in this test phase of the treatment?
"This clinical trial needs 63 eligible participants. The inclusion criteria for this study are specified on the website. Those who meet these qualifications and live near either Laura and Isaac Perlmutter Cancer Center at NYU Langone in New york, New York or University of Pennsylvania Abramson Cancer Center in Philadelphia, Pennsylvania are encouraged to apply."
Answered by AI
What is the primary indication for Rituximab?
"Rituximab is an effective treatment for patients suffering from inflammatory breast cancer (IBC), b-cell lymphomas, and polyangiitis."
Answered by AI
Are there any geographical restrictions to participating in this research?
"There are 7 sites recruiting patients for this study, including the Laura and Isaac Perlmutter Cancer Center at NYU Langone in New york, University of Pennsylvania Abramson Cancer Center in Philadelphia, Mayo Clinic in Rochester in Rochester, as well as other locations."
Answered by AI
Are people still being recruited to participate in this trial?
"Yes, this is an ongoing study that is currently recruiting patients. The trial was first posted on 4/1/2021 and was most recently edited on 8/25/2022. The study is looking for 63 participants between 7 sites."
Answered by AI
Has Rituximab been federally sanctioned for medical use?
"Rituximab's safety has been studied to some extent, but there is no data indicating that it is an effective treatment. Consequently, it received a score of 2."
Answered by AI
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