Spots Global Cancer Trial Database for CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma

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Trial Identification

Brief Title: CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma

Official Title: Pilot Study of CPI-613, in Combination With Bendamustine, in Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma

Study ID: NCT04217317

Conditions

Relapsed T-Cell Lymphoma

Refractory T-Cell Lymphoma

Non Hodgkin Lymphoma

Interventions

CPI 613

Bendamustine

Study Description

Brief Summary: 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.

Detailed Description: 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.