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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04217317
Study type Interventional
Source Wake Forest University Health Sciences
Contact Brittany Mabe, RN
Phone 336-716-5440
Email bmabe@wakehealth.edu
Status Recruiting
Phase Phase 2
Start date September 16, 2020
Completion date June 2025

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