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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Number of Participants To Successfully Complete Therapy Regimen
Number of patients successfully able to complete 80% (at least 5 of 6 planned cycles) of their therapy regimens.
Time frame: up to 6 cycles, up to 24 weeks after first dose
Overall Response Rate
Overall response rate is defined as the proportion of patients who achieve a best overall response complete response or partial response during or following study treatment. Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: The Lugano classification.
Time frame: Patients are monitored for best overall response during and after study treatment. Follow-up for response ranged from 2 to 6 months after start of treatment.
Disease Control Rate
Disease control rate defined as the proportion of patients who achieve a best overall response of complete response, partial response, or stable disease (SD). Best overall response of stable disease must have met the response stable disease criteria at least once ≥12 weeks after start of study treatment. Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients
Time frame: Patients are monitored for response during and after study treatment. Follow-up for response ranged from 2 to 6 months after start of treatment.
Duration of Response
Duration of Response will be defined for responders (patients with a best overall response of complete response or partial response). It is the time from the date of the first documented complete response or partial response until the date of the first date of progressive disease, or death due to any cause, whichever occurs first. If a patient has not progressed or died by the analysis cutoff date, duration of response will be censored at the time of the last adequate tumor assessment on or before the cutoff date. Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients.
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Time frame: Patients are monitored for response during and after study treatment. Follow-up for response ranged from 2 to 6 months after start of treatment.
Progression Free Survival
Progression free survival defined as the time from the start of study treatment until the first date of progressive disease, or death due to any cause, whichever occurs first. If a patient has not progressed or died by the analysis cutoff date, progression free survival will be censored at the time of the last adequate tumor assessment on or before the cutoff date. Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients
Time frame: Patients are monitored for progression during and after study treatment. Follow-up for response ranged from 2 to 6 months after start of treatment.
Overall Survival
Overall survival is measured from the start of study treatment until death due to any cause. If a patient is not known to have died at the date of the analysis cut-off, overall survival will be censored at the last date that: Patient is documented to be alive. At the time of single cell sequencing.
Time frame: Maximum observed follow-up of 3 years 9 months