DS-3201b in Participants With Lymphomas

This is an interventional treatment trial for Lymphoma, Malignant focused on measuring Adult T-cell leukemia-lymphoma (ATL), Peripheral T-cell lymphoma (PTCL), Cutaneous T-cell lymphoma (CTCL), B-cell lymphoma Read More

Inclusion Criteria:

• Has hematocytological or pathological diagnosis of non- Hodgkin's lymphoma (NHL)
• Has relapsed from or is refractory to standard treatment or no standard treatment is available
• Is the age of majority in their country (18 in the US and 20 in Japan) at the time of informed consent
• Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Has at least one evaluable lesion site (not applicable for the DDI cohort)
• Has preserved organ function based on baseline laboratory data at screening tests
• If of reproductive potential, agrees to avoid harvesting ova or sperm, and to use a protocol-defined form of contraception or avoid intercourse, during and upon completion of the study, and for at least 3 months after the last dose of study drug

• Tumor biopsy collections:

  1. willing to provide archived or fresh tumor tissue samples that are sufficient for comprehensive genomic and/or proteomic analyses at baseline

  2. [US only] willing to provide fresh on-treatment tumor biopsy if deemed acceptable risk by the investigator

     [Japan only] fresh on-treatment tumor biopsy should be performed if deemed acceptable risk by the investigator

  3. willing to provide optional fresh end-of-treatment biopsy

For ATL subjects:

• Has a positive test result for human T-lymphotropic virus type I antibody
• Has ATL subtype classified as acute, lymphomatous, or chronic with poor prognostic factor
• Has diagnosis of relapse (including relapse after partial remission [PR]) or treatment-resistant ATL at the time of informed consent after prior treatment with at least 1 anti-cancer medication regimen

Exclusion Criteria:

• Has been diagnosed with protocol-defined cutaneous T-cell lymphoma or T-cell leukemia. For DDI cohort, CTCL is not exclusionary.
• Has a history or presence of central nervous system (CNS) involvement
• Has a medical history, complication or other malignancy considered inappropriate for participation in the study, or a serious physical or psychiatric disease, the risk of which may be increased by participation in the study
• Has received drugs or other treatments not allowed by the protocol
• History of treatment with other enhancer of zeste (EZH) inhibitors
• Has had allogeneic hematopoietic stem cell transplantation (HTCP) within 90 days before scheduled dosing on Cycle 1 Day 1
• Is pregnant or breastfeeding
• Is otherwise deemed ineligible to participate by the investigator or sub-investigator

DDI Cohort Only:

• Has received following medications within 14 days prior to study drug administration
• Any CYP3A inhibitors/inducers including weak CYP3A inhibitors/inducers, and P-gp inhibitors, midazolam as well as digoxin