Venetoclax and Romidepsin in Treating Patients With Recurrent or Refractory Mature T-Cell Lymphoma (NCT03534180) | Clinical Trial Compass
CompletedPhase 2
Venetoclax and Romidepsin in Treating Patients With Recurrent or Refractory Mature T-Cell Lymphoma
United States12 participantsStarted 2018-08-21
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
* Ab…
What they're measuring
1
Number of Patients With Grade 3 or Above Toxicities
Timeframe: Up to 30 days post-treatment, an average of 4 months.