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

NCT05683171 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2022-0551NCI-2023-00072
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion; an average of 1 year.

Study Arms (1)

Phase 1 Dose Escalation

EXPERIMENTAL

The dose escalation phase will assess the safety/tolerability of escalating doses of valemetostat and lenalidomide when combined with rituximab

Drug: Rituximab; Drug: Lenalidomide; Drug: Valemetostat

Interventions

Valemetostat DRUG

Given by PO

Phase 1 Dose Escalation

Rituximab DRUG

Given by IV (vein)

Also known as: Rituxan

Phase 1 Dose Escalation

Lenalidomide DRUG

Given by PO

Also known as: CC-5013, Revlimid™

Phase 1 Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the eligibility criteria to be enrolled on this study.
• Subjects ≥18 years of age at the time the ICF is signed.
• Have histologically confirmed FL, grades 1-3A
• Must have been previously treated with at least 1 prior systemic therapy followed by relapsed, refractory or progressive disease.
• a. Systemic therapy includes: i. Anti-CD20 monoclonal antibody in combination with chemotherapy ii. Anti-CD20 monoclonal antibody monotherapy iii. Anti-CD20 monoclonal antibody in combination with lenalidomide iv. Anti-CD20 monoclonal antibody plus investigational agent on protocol
• Requiring systemic therapy as assessed by investigator based on tumor size, location, and/or GELF criteria.
• Bi-dimensionally measurable disease, with at least one mass lesion ≥ 2 cm in longest diameter by CT, PET/CT, and/or MRI which was not previously irradiated.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Adequate renal function defined as calculated creatinine clearance per the Cockcroft and Gault formula
• In phase 1, creatinine clearance must be \>60 mL/minute
• In Phase 2, creatinine clearance must be ≥30 mL/minute.
• Adequate bone marrow function:
• Absolute neutrophil count (ANC) ≥1,000/mm3 (≥1.0 × 109/L) if no lymphoma infiltration of bone marrow OR ANC ≥750/mm3 (≥0.75 × 109/L) with bone marrow infiltration, without growth factor support (filgrastim or pegfilgrastim) for at least 14 days.
• Platelet ≥75,000/mm3 (≥75 × 109/L). Evaluated at least 7 days after platelet transfusion.
• Hemoglobin \> 8.0 g/dL. Evaluated at least 7 days after RBC transfusion.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from study entry.
• Transformation to DLBCL at study entry
• Grade 3B FL
• Prior systemic therapy (eg, chemotherapy, immunomodulatory therapy, or monoclonal antibody therapy) within 3 weeks prior to the first dose of study drug.
• 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
• 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
• Systemic treatment with corticosteroids (\>10 mg daily prednisone equivalents). Note: Short-course systemic corticosteroids (eg, prevention/treatment for transfusion reaction) or use for a non-cancer indication (eg, adrenal replacement) is permissible
• History of autologous stem cell transplant within 60 days prior to first dose of study drug
• 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
• Prior malignancy active within the previous 2 years except for locally curable cancer that is currently considered as cured, such as cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer
• Presence or history of central nervous system (CNS) involvement of lymphoma
• Prior EZH inhibitor therapy
• Current use of moderate or strong cytochrome P450 (CYP)3A inducers (See Appendix E) or inhibitors, or prior use of moderate or strong CYP3A within the past 2 weeks.
• Current use of P-gp inducers and on narrow therapeutic index, sensitive P-gp substrates.
• Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of lenalidomide capsules, or put the study outcomes at undue risk

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Daiichi Sankyo: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma

Interventions

Rituximab; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chijioke Nze, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chijioke Nze, MD

CONTACT

832-729-1752; ccnze@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: May 19, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)