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Anti-tumor antibiotic

Rituximab + Pembrolizumab +/- Lenalidomide for Lymphoma

Phase 2

Waitlist Available

Led By Ranjit Nair

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

Must not have

Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment

Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events (AEs) due to agents administered more than 4 weeks earlier

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after the completion of study treatment

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

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

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

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I haven't had a monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.

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I am currently being treated for an infection.

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I have been treated with specific immune system targeting drugs before.

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I have lung conditions that needed steroids or have current lung inflammation.

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I have been diagnosed with HIV.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after the completion of study treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall response rate (complete + partial responses)

Secondary study objectives

Complete response rate

Incidence of toxicity

Overall survival

+1 more

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

Awards & Highlights

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.

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

0 / 11Eligibility criteria met