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Immunomodulatory Agent
Valemetostat + Rituximab + Lenalidomide for Follicular Lymphoma
Phase 1 & 2
Recruiting
Led By Loretta Nastoupil, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will explore the safety & effects of combining valemetostat, rituximab & lenalidomide for treating follicular lymphoma.
Who is the study for?
Adults with previously treated, relapsed or refractory follicular lymphoma (grades 1-3A) who need systemic therapy. Participants must have measurable disease, be in good physical condition (ECOG ≤2), and have proper kidney, liver, and bone marrow function. Women of childbearing potential must use effective birth control methods.
What is being tested?
The trial is testing the combination of valemetostat with rituximab and lenalidomide to determine a safe dosage and assess its effects on patients with follicular lymphoma who have had previous treatments but their disease has returned or did not respond.
What are the potential side effects?
Potential side effects may include reactions related to the immune system, blood disorders, kidney or liver issues due to drug interactions. Specific side effects for valemetostat are not listed but could be similar to other drugs in its class.
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
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: Phase 1 Dose EscalationExperimental Treatment3 Interventions
The dose escalation phase will assess the safety/tolerability of escalating doses of valemetostat and lenalidomide when combined with rituximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~2990
Lenalidomide
2005
Completed Phase 3
~2240
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,586 Total Patients Enrolled
259 Trials studying Lymphoma
32,475 Patients Enrolled for Lymphoma
Daiichi SankyoIndustry Sponsor
415 Previous Clinical Trials
465,348 Total Patients Enrolled
10 Trials studying Lymphoma
636 Patients Enrolled for Lymphoma
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
422,810 Total Patients Enrolled
10 Trials studying Lymphoma
636 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition has progressed to diffuse large B-cell lymphoma.My kidney function, measured by creatinine clearance, meets the trial's requirement.I have a tumor larger than 2 cm that has not been treated with radiation.I am not pregnant, breastfeeding, and do not have heart issues or infections.My condition is Grade 3B Follicular Lymphoma.My condition worsened on lenalidomide or I was treated with it in the last year.I had radiation or major surgery within the allowed time before starting the study drug.I can take care of myself and am up and about more than half of my waking hours.My kidneys are working well, as shown by a creatinine clearance test.I am 18 years old or older.I haven't had any cancer treatment in the last 3 weeks.My blood tests show my bone marrow is working well.My condition worsened after my first treatment.My liver is functioning well, according to specific blood tests.My lymphoma is confirmed to be Follicular Lymphoma, grades 1-3A.My doctor thinks I need treatment based on my tumor's size or location.I am a man who is either surgically sterile or willing to use effective birth control.I have a history of specific treatments or conditions, including stem cell transplants or prior cancers.I am not pregnant and agree to use effective birth control.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Dose Escalation
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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