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OncoMatch/Clinical Trials/NCT05683171

A Phase 1/2, Open-label Study of Valemetostat in Combination With Rituximab and Lenalidomide in Relapsed or Refractory Follicular Lymphoma

Is NCT05683171 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Rituximab and Lenalidomide for lymphoma.

Phase 1/2RecruitingM.D. Anderson Cancer CenterNCT05683171Data as of May 2026

Treatment: Rituximab · Lenalidomide · ValemetostatTo 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

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: systemic therapy

Must have been previously treated with at least 1 prior systemic therapy followed by relapsed, refractory or progressive disease

Cannot have received: systemic therapy

Prior systemic therapy (eg, chemotherapy, immunomodulatory therapy, or monoclonal antibody therapy) within 3 weeks prior to the first dose of study drug

Cannot have received: lenalidomide (lenalidomide)

Having progressive disease while on prior lenalidomide, discontinuing lenalidomide due to unacceptable toxicity, or prior lenalidomide therapy within the past 12 months prior to the first dose of study drug

Cannot have received: curative radiation therapy

Had curative radiation therapy or major surgery within 4 weeks or palliative radiation therapy within 2 weeks prior to the first dose of study drug

Cannot have received: autologous stem cell transplant

History of autologous stem cell transplant within 60 days prior to first dose of study drug

Cannot have received: allogeneic stem cell transplant

History of allogeneic stem cell transplant within 90 days prior to the first dose of study drug, and clinically significant graft-versus-host disease (GVHD) or GVHD requiring systemic immunosuppressive prophylaxis or treatment

Cannot have received: EZH inhibitor

Prior EZH inhibitor therapy

Lab requirements

Blood counts

ANC ≥1,000/mm3 (no marrow infiltration) or ≥750/mm3 (with infiltration), no growth factor support for ≥14 days; Platelet ≥75,000/mm3, evaluated ≥7 days after transfusion; Hemoglobin >8.0 g/dL, evaluated ≥7 days after RBC transfusion

Kidney function

Calculated creatinine clearance per Cockcroft and Gault formula; Phase 1: >60 mL/min, Phase 2: ≥30 mL/min

Liver function

Total bilirubin ≤1.5 × ULN except for unconjugated hyperbilirubinemia of Gilbert's syndrome (<3.0 mg/dL); ALT and AST ≤3 × ULN

Adequate renal function... Adequate bone marrow function... Adequate liver function...

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • M D Anderson Cancer Center · Houston, Texas

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