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Anti-tumor antibiotic
Rituximab + Pembrolizumab +/- Lenalidomide for Lymphoma
Phase 2
Waitlist Available
Led By Loretta J Nastoupil
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For cohort 1: Male or female subjects with histologic proof of follicular lymphoma grade 1, 2, or 3a relapsing after at least one prior systemic therapy that included rituximab (or other monoclonal CD20 antibody); patients should have documented rituximab-sensitive disease defined as a documented complete or partial response lasting at least 6 months after the last rituximab-containing therapy
For cohort 2: Male or female subjects with histologic proof of follicular lymphoma grade 1, 2, or 3a relapsing after at least two prior systemic therapies, which must include CAR T cell therapy or histologic proof of DLBCL relapsing after at least two prior systemic therapies, which must include CAR T cell therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after the completion of study treatment
Awards & highlights
Study Summary
This trial will study how well rituximab and pembrolizumab with or without lenalidomide works in treating patients with follicular lymphoma or diffuse large B-cell lymphoma that has returned after a period of improvement.
Who is the study for?
This trial is for adults with relapsed follicular lymphoma or diffuse large B-cell lymphoma after at least one prior therapy including rituximab, or two therapies with CAR T cell treatment. Participants must have adequate organ function, not be pregnant or breastfeeding, agree to use contraception, and cannot have certain infections like HIV or hepatitis.Check my eligibility
What is being tested?
The study tests the effectiveness of combining rituximab and pembrolizumab with or without lenalidomide in treating patients whose lymphoma has returned. It examines how these drugs might help the immune system fight cancer and stop tumor growth.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from receiving drugs through a vein, fatigue, blood disorders such as low counts that increase infection risk, and possible harm to an unborn baby.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have follicular lymphoma that responded to previous treatment with rituximab for at least 6 months.
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I have relapsed follicular lymphoma or DLBCL and have had at least two treatments, including CAR T therapy.
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My cancer can be measured and is at least 1.5 cm big.
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My kidney function tests are within the required range.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after the completion of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after the completion of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (complete + partial responses)
Secondary outcome measures
Complete response rate
Incidence of toxicity
Overall survival
+1 moreSide effects data
From 2016 Phase 2 & 3 trial • 86 Patients • NCT030020384%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort II (rituximab, pembrolizumab, lenalidomide)Experimental Treatment4 Interventions
Patients receive rituximab IV over 4-8 hours on days 1, 8 and 15 of cycle 1, and day 1 of cycle 2. Patients also receive pembrolizumab IV over 1 hour on day 2 every 3 weeks for up to 2 years, and lenalidomide PO on days 1-14 every 3 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Cohort I (rituximab, pembrolizumab)Experimental Treatment3 Interventions
Patients receive rituximab IV over 4-8 hours on days 1, 8, 15, and 22. Patients also receive pembrolizumab IV over 1 hour on day 2 every 3 weeks for up to 16 cycles (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
FDA approved
Lenalidomide
FDA approved
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,614 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,749 Total Patients Enrolled
Loretta J NastoupilPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
142 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have fully recovered from any major surgery before starting treatment.I have relapsed follicular lymphoma or DLBCL and have had at least two treatments, including CAR T therapy.I have been treated with specific immune system targeting drugs before.I have previously been treated with pidilizumab.My kidney function tests are within the required range.My liver function tests are within the required range.I am a woman able to have children and agree to use two birth control methods or abstain from sex during the study and for 120 days after.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I haven't had a monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.I haven't had cancer treatment in the last 2 weeks or I've recovered from side effects, except for mild neuropathy.I have another cancer besides the one being studied, but it's either not progressing or is a type that doesn't need active treatment.I had CNS lymphoma or meningitis but am stable now without steroids for 7 days.My cancer can be measured and is at least 1.5 cm big.I am currently being treated for an infection.I have follicular lymphoma that responded to previous treatment with rituximab for at least 6 months.My blood platelet count is at least 50 x 10^9/L.I agree to follow the pregnancy testing schedule required by the Revlimid REMS program.I have not received a live vaccine in the last 30 days.I am fully active or restricted in physically strenuous activity but can do light work.I have lung conditions that needed steroids or have current lung inflammation.My blood clotting time is normal or managed with medication.My white blood cell count is high enough for treatment.I have been diagnosed with HIV.My blood clotting time is normal or managed if I'm on blood thinners.I agree to use two forms of birth control during and for 120 days after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort II (rituximab, pembrolizumab, lenalidomide)
- Group 2: Cohort I (rituximab, pembrolizumab)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
How many volunteers are being sought for this experiment?
"Affirmative. Clinicaltrials.gov reveals that this trial is actively enrolling patients, with a listing dating back to July 31st 2015 and an update on October 31st 2022. This medical experiment requires 72 participants from one site specifically."
Answered by AI
Are there still opportunities for individuals to partake in this experiment?
"Affirmative. The information found on clinicaltrials.gov confirms that this medical trial, which was initially posted on July 31st 2015, is actively enrolling participants. A total of 72 individuals need to be recruited from 1 site for the study's completion."
Answered by AI
Is Rituximab compliant with the guidelines set by the Food and Drug Administration?
"Due to Rituximab's Phase 2 status, the safety of this drug was assessed as a level 2 on our rating system. This indicates that some data exists indicating its safety but there is an absence of information on efficacy."
Answered by AI
For what maladies is Rituximab typically prescribed?
"Rituximab is the standard treatment for malignant melanoma of the skin. It has also been used to reduce symptoms and increase survival rates in recurrent cervical cancer, refractory or relapsed mediastinal large B-cell lymphoma, as well as chronic lymphocytic leukemia."
Answered by AI
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