Study on Valemetostat Tosylate for Treating Relapsed or Hard-to-Treat Peripheral T-Cell Lymphoma

Inclusion Criteria

• Must provide written informed consent.
• Must be 18 years or older.
• Must have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
• For Cohort 1: Must have relapsed or refractory peripheral T-cell lymphoma confirmed by a local pathologist. Eligible subtypes include:
  • Enteropathy-associated T-cell lymphoma
  • Monomorphic epitheliotropic intestinal T-cell lymphoma
  • Hepatosplenic T-cell lymphoma
  • Primary cutaneous γδ T-cell lymphoma
  • Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma
  • PTCL, not otherwise specified
  • Angioimmunoblastic T-cell lymphoma
  • Follicular T-cell lymphoma
  • Nodal PTCL with T-follicular helper (TFH) phenotype
  • Anaplastic large cell lymphoma, ALK positive or negative
• For Cohort 2: Must have relapsed or refractory adult T-cell leukemia/lymphoma confirmed by a local pathologist and positive for HTLV-1 antibody.
• Must have at least one measurable lesion on a scan.
• Must have documented disease progression after at least one prior treatment.
• Must be ineligible for hematopoietic cell transplantation due to active disease or other factors.
• Participants with anaplastic large cell lymphoma must have had prior brentuximab vedotin treatment.

Exclusion Criteria

• Diagnosis of mycosis fungoides, Sézary syndrome, or primary cutaneous ALCL.
• Diagnosis of precursor T-cell leukemia and lymphoma, T-cell prolymphocytic leukemia, or T-cell large granular lymphocytic leukemia.
• Active cancer within the last 2 years, except for certain skin cancers or localized prostate cancer.
• Active central nervous system involvement of lymphoma.
• Recent history of stem cell transplantation.
• Significant heart problems or uncontrolled cardiovascular conditions.
• Previous treatment with other EZH inhibitors.
• Current use of certain medications that affect liver enzymes.
• Use of high-dose corticosteroids.
• Known allergy to valemetostat tosylate or its ingredients.