Actively Recruiting
A Phase 1/2, Open-label Study of Valemetostat in Combination with Rituximab and Lenalidomide in Relapsed or Refractory Follicular Lymphoma
Led by M.D. Anderson Cancer Center · Updated on 2026-05-15
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying valemetostat combined with rituximab and lenalidomide to find a safe and recommended dose for patients with relapsed or refractory follicular lymphoma. This Phase 1/2 open-label study aims to evaluate the safety, tolerability, and effects of this drug combination, including its impact on gene expression and tumor environment in this type of lymphoma. The study includes a dose escalation phase to assess increasing doses of valemetostat and lenalidomide with rituximab. Treatments are given by vein (rituximab) and by mouth (valemetostat and lenalidomide). The trial has two phases: Phase 1 focuses on safety, tolerability, and initial effectiveness, while Phase 2 evaluates the overall response rate, duration of response, progression-free survival, and other outcomes. Participants will undergo regular assessments including safety monitoring for adverse events, measurements of tumor size by imaging, laboratory tests for kidney, liver, and bone marrow function, and pharmacokinetic studies. The main outcome measured is the incidence of adverse events graded by standard criteria over about one year. The study is expected to continue until September 2027, with participants closely monitored throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
A Phase 1/2, Open-label Study of Valemetostat in Combination With Rituximab and Lenalidomide in Relapsed or Refractory Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Histologically confirmed follicular lymphoma grades 1 to 3A
- Previously treated with at least one prior systemic therapy and have relapsed, refractory, or progressive disease
- Require systemic therapy based on tumor size, location, or GELF criteria
- Have at least one measurable mass lesion 2 cm or larger by CT, PET/CT, or MRI, not previously irradiated
- ECOG performance status of 2 or less
- Adequate renal function: creatinine clearance >60 mL/min for Phase 1, or ≥30 mL/min for Phase 2
- Adequate bone marrow function with specified blood counts
- Adequate liver function within defined limits
- INR and aPTT within defined limits (unless on warfarin with INR ≤3.0)
- For females of childbearing potential: negative pregnancy test and agreement to use effective birth control during and 3 months after treatment
- For males: surgically sterile or agree to use effective birth control during and 3 months after treatment
- Willingness to comply with Revlimid REMS® program requirements
- Able and willing to give informed consent and follow study procedures
You will not qualify if you...
- Transformation to diffuse large B-cell lymphoma at entry
- Grade 3B follicular lymphoma
- Systemic therapy within 3 weeks prior to first study drug dose
- Progressive disease on prior lenalidomide, unacceptable toxicity from lenalidomide, or lenalidomide use within 12 months prior
- Curative radiation or major surgery within 4 weeks, or palliative radiation within 2 weeks before first dose
- Systemic corticosteroids above 10 mg prednisone equivalents (except short-course or non-cancer use)
- Autologous stem cell transplant within 60 days before first dose
- Allogeneic stem cell transplant within 90 days before first dose or active graft-versus-host disease requiring treatment
- Prior malignancy active within 2 years except certain cured or superficial cancers
- Central nervous system involvement of lymphoma
- Prior EZH inhibitor therapy
- Use of moderate or strong CYP3A inducers or inhibitors within 2 weeks prior
- Use of P-gp inducers or sensitive P-gp substrates
- Life-threatening illness or organ dysfunction compromising safety or study outcomes
- Active infections including HIV or active hepatitis B or C
- Significant cardiovascular disease or major ECG abnormalities
- Lactating or pregnant females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year or until disease progression or unacceptable toxicity
Participants receive valemetostat in combination with rituximab and lenalidomide to treat relapsed or refractory follicular lymphoma.
Regular visits for treatment administration and monitoring as per protocol
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Chijioke Nze, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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