CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT04217317|
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Relapsed T-Cell Lymphoma Refractory T-Cell Lymphoma Non Hodgkin Lymphoma||Drug: CPI 613 Drug: Bendamustine||Phase 2|
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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of CPI-613, in Combination With Bendamustine, in Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2025|
Experimental: CPI-613 in Combination with Bendamustine
CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.
Drug: CPI 613
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.
Other Name: devimistat
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.
- Number of Participants To Successfully Complete Therapy Regimen [ Time Frame: 8 weeks after first dose ]Feasibility will be defined as 75% of patients being successfully able to complete 80% of their therapy regimens. Toxicity data will be collected on all patients who receive at least one dose of treatment on the study
- Overall Response Rate [ Time Frame: Up to 12 weeks post treatment ]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 according to the Lugano Classification (Stage I - involvement in a single lymph node region to Stage IV diffuse or disseminated involvement of one or more extranodal organs or tissue).
- Disease Control Rate [ Time Frame: Up to 12 weeks post treatment ]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.
- Duration of Response [ Time Frame: Up to 12 weeks post treatment ]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.
- Progression Free Survival [ Time Frame: Up to 12 weeks post treatment ]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.
- Overall Survival [ Time Frame: Up to 5 years post treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217317
|Contact: Brittany Mabe, RNfirstname.lastname@example.org|
|Contact: Tong Chen, RNemail@example.com|
|United States, North Carolina|
|Wake Forest Baptist Comprehensive Cancer Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Tong Chen, RN firstname.lastname@example.org|
|Contact: Brittany Choi, RN email@example.com|
|Principal Investigator: Rakhee Vaidya, MBBS|
|Principal Investigator:||Rakhee Vaidya, M.B.B.S.||Wake Forest University Health Sciences|