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 2026-03-13
60
Participants Needed
1
Research Sites
227 weeks
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
To find a recommended dose of valemetostat that can be given in combination with rituximab and lenalidomide to patients with follicular lymphoma. The safety and effects of this drug combination will also be studied
CONDITIONS
Official 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 time of consent
- Histologically confirmed follicular lymphoma grades 1 to 3A
- Previously treated with at least one prior systemic therapy resulting in relapsed, refractory, or progressive disease
- Prior systemic therapies include anti-CD20 antibody with chemotherapy, anti-CD20 antibody alone, anti-CD20 antibody with lenalidomide, or anti-CD20 antibody with investigational agents
- Require systemic therapy based on tumor size, location, or GELF criteria
- At least one measurable mass lesion 2 cm or larger by CT, PET/CT, or MRI, not previously irradiated
- ECOG performance status of 0, 1, or 2
- Adequate renal function with creatinine clearance over 60 mL/min (Phase 1) or at least 30 mL/min (Phase 2)
- Adequate bone marrow function with specified neutrophil counts, platelet counts, and hemoglobin levels
- Adequate liver function with bilirubin, ALT, and AST within defined limits
- INR and aPTT within specified ranges unless on warfarin
- Females of childbearing potential must have negative pregnancy test and agree to use effective contraception during and for 3 months after treatment
- Males must be surgically sterile or agree to use effective contraception during and for 3 months after treatment
- Females must not donate or retrieve eggs during and for 3 months after treatment
- All participants must register and comply with the Revlimid REMS program
- Able and willing to provide informed consent and follow study requirements
You will not qualify if you...
- Diagnosis of diffuse large B-cell lymphoma (DLBCL) transformation at study entry
- Follicular lymphoma grade 3B
- Systemic therapy within 3 weeks before first study drug dose
- Progressive disease on prior lenalidomide or lenalidomide within 12 months before study drug
- Recent curative radiation or major surgery within 4 weeks or palliative radiation within 2 weeks before study drug
- Use of systemic corticosteroids over 10 mg prednisone daily (except short-course or non-cancer use)
- Autologous stem cell transplant within 60 days before study drug
- Allogeneic stem cell transplant within 90 days before study drug or significant graft-versus-host disease
- Prior malignancy active within 2 years except certain cured cancers
- Central nervous system involvement of lymphoma
- Prior therapy with EZH inhibitors
- Current or recent use of CYP3A or P-gp inducers or inhibitors
- Life-threatening illness or organ dysfunction that risks safety or study outcomes
- Active infections including HIV, Hepatitis B or C
- Significant heart disease or recent heart attack
- Certain abnormal ECG findings
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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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
CONTACT
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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