Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Non Hodgkin Lymphoma
  • Refractory T-Cell Lymphoma
  • Relapsed T-Cell Lymphoma
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04217317
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Rakhee Vaidya, M.B.B.S. Wake Forest University Health Sciences