Non Hodgkin Lymphoma Clinical Trial
Official title:
Pilot Study of CPI-613, in Combination With Bendamustine, in Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma
The purpose of this study is to determine if it is possible to give CPI-613 with the drug Bendamustine for 2 days every 28 days without causing severe side effects. In addition, this study will also test the safety of CPI-613 when given in combination with Bendamustine.
Primary Objectives: A pilot Study to evaluate the feasibility, safety and tolerability of a two day course per cycle of Bendamustine plus CPI-613 in patients with relapsed and refractory T cell non-hodgkin lymphoma. Exploratory Objectives To evaluate: - Overall response rate (ORR) and disease control rate (DCR) derived from the Lugano classification. - Duration of response (DOR) derived from the Lugano classification. - Progression-Free-Survival (PFS) derived from Lugano classification. - Overall Survival (OS). - Single cell transcriptomics from PMBCs pre- and post-treatment; for correlative analyses of blood PBMC (and possibly excess pre-treatment tumor biopsy) cell population diversity and functional states to reveal potential mechanisms of drug treatment with regard to patient response status. ;
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