A Phase 2 Study of Venetoclax and Romidepsin With Safety Lead-In for Treatment of Relapsed/Refractory Mature T-Cell Lymphomas
This phase II trial studies the side effects and best dose of venetoclax and romidepsin to see how well it works in treating patients with mature T-cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax and romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
• Documented informed consent of the participant and/or the legally authorized representative
• Be willing to provide tissue
• Eastern Cooperative Oncology Group (ECOG) =\< 2
• Resolution of all acute toxic effects of prior therapy or surgical procedures to Common Terminology Criteria for Adverse Events (CTCAE) grade =\< 1 (except alopecia)
• Failed at least 2 prior systemic therapies. For anaplastic large cell lymphoma (ALCL) histologies this must include failure or intolerable side effects of brentuximab vedotin
• Histologically confirmed peripheral T-cell lymphoma (PTCL) as defined by the World Health Organization (WHO) criteria 2016, excluding cutaneous T-cell lymphoma (CTCL); transformed mycosis fungoides is allowed
• Measurable disease defined as:
‣ Computed tomography (CT)/magnetic resonance imaging (MRI)/ or positron emission tomography (PET) scan, with at least one nodal site of disease which is 1.5 cm in longest dimension, and/or spleen \> 13 cm in vertical length, and/or diffuse enlargement of liver with or without focal nodules (Lugano 2014); extra nodal sites with biopsy proven abnormal lesions are allowed including skin
⁃ Patients with only bone marrow involvement will be acceptable
• Prior stem cell transplant allowed
‣ If allogeneic hematopoietic cell transplantation (HCT) must have recovered from acute toxicity
⁃ Cannot have active acute or chronic graft versus host disease (GvHD) and must be off immunosuppressive therapies
• Absolute neutrophil count (ANC) \>= 1,000/mm\^3 (to be performed within 14 days prior to day 1 of protocol therapy)
‣ NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement
⁃ Exception: Unless documented bone marrow involvement by lymphoma
• Platelets \>= 30,000/mm\^3 (to be performed within 14 days prior to day 1 of protocol therapy)
‣ NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement
⁃ Exception: Unless documented bone marrow involvement by lymphoma
• Total bilirubin =\< 1.5 x upper limit of normal (ULN) (=\< 3 x ULN for Gilbert's syndrome or documented hepatic involvement by lymphoma) (to be performed within 14 days prior to day 1 of protocol therapy)
• Aspartate aminotransferase (AST) =\< 3 x ULN (to be performed within 14 days prior to day 1 of protocol therapy)
‣ If hepatic involvement by lymphoma: AST =\< 5 x ULN
• Alanine aminotransferase (ALT) =\< 3 x ULN (to be performed within 14 days prior to day 1 of protocol therapy)
‣ If hepatic involvement by lymphoma: ALT =\< 5 x ULN
• Creatinine clearance of \>= 50 mL/min per 24 hour urine or the Cockcroft-Gault formula (to be performed within 14 days prior to day 1 of protocol therapy)
• Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
‣ If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Agreement by WOCBP and males of childbearing potential\* to use an adequate method of birth control (hormonal contraception is inadequate) or abstain from heterosexual activity for the course of the study through 90 days after the last dose of protocol therapy
‣ Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)