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CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma | Clinical Trials | Clareo Health

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CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma

Phase I Dose-Escalation Study of CPI-613, in Combination With Bendamustine, in Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Classic Hodgkin Lymphoma

NCT02168140•Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and best dose of CPI-613 when given together with bendamustine hydrochloride in treating patients with relapsed or refractory T-cell non-Hodgkin lymphoma or Hodgkin lymphoma. CPI-613 may kill cancer cells by turning off their mitochondria, which are used by cancer cells to produce energy and are the building blocks needed to make more cancer cells. By shutting off mitochondria, CPI-613 may deprive the cancer cells of energy and other supplies needed to survive and grow. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CPI-613 with bendamustine hydrochloride may kill more cancer cells.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of CPI-613 \[6,8-bis(benzylthio)octanoic acid\], when used in combination with bendamustine (bendamustine hydrochloride) in patients with relapsed and refractory classic Hodgkin lymphoma (HL) or T-cell non-Hodgkin lymphoma (NHL) who have or have not received hematopoietic cell transplant. SECONDARY OBJECTIVES: I. To evaluate response rate (RR) and disease control rate (DCR), derived from the modified International Work Group (IWG) criteria and International Cutaneous Lymphoma (Olsen criteria) for cutaneous lymphomas. II. To evaluate overall survival (OS) and progression-free survival (PFS), and possible correlation between RR and DCR derived from modified IWF criteria vs. OS and PFS. III. To evaluate assessment of bone marrow biopsy, and possible correlation between complete response (CR) vs. bone marrow biopsy assessment (e.g., clear of infiltration of leukemic cells according to morphology, and/or negative on leukemic cells according to immunohistochemistry). IV. To evaluate safety of CPI-613 + bendamustine combination. OUTLINE: This is a dose-escalation study of 6,8-bis(benzylthio)octanoic acid. Patients receive 6,8-bis(benzylthio)octanoic acid intravenously (IV) over 2 hours on days 1-4 of week 1 and on days 1 and 4 of weeks 2 and 3. Patients also receive bendamustine hydrochloride IV over 30 minutes on days 4 and 5 of week 1. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed T-cell NHL or classic HL (i.e., nodular sclerosis HL, mixed cellularity HL, lymphocyte rich classic HL, and lymphocyte depleted HL) that has relapsed from, or is refractory to, all standard therapies (including autologous transplantation) known to provide clinical benefit, but have not been treated with bendamustine for their lymphoma
•Must have measurable disease (e.g., a tumor mass \> 1 cm)
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•Expected survival \> 3 months
•Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
•Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists
•At least 2 weeks must have elapsed from any prior surgery
•Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 3 x upper normal limit (UNL), alanine aminotransferase (ALT/serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x UNL (=\< 5 x UNL if liver metastases present)
•Bilirubin =\< 1.5 x UNL
•Serum creatinine =\< 1.5 mg/dL or 133 µmol/L
+3 more criteria

Exclusion Criteria

•Known cerebral metastases, central nervous system (CNS) or epidural tumor
•Having "currently active" second malignancy unrelated to HL or NHL, unless they have completed anti-cancer therapy, are in complete response and are considered by their physicians to be at less than 30% risk of relapse
•Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of treatment with study drugs
•Serious medical illness that would potentially increase patients' risk for toxicity
•Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease)
•History of abdominal fistula or gastrointestinal perforation =\< 6 months prior to treatment with study drugs
•Pregnant women, or women of child-bearing potential not using reliable means of contraception
•Lactating females
•Fertile men unwilling to practice contraceptive methods during the study period
•Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
+7 more criteria

Locations (2)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

September 1, 2014

Primary Completion Date

April 18, 2019

Completion Date

September 15, 2022

Last Updated

February 13, 2024

Enrollment

ACTUAL participants

Conditions

Adult Lymphocyte Depletion Hodgkin LymphomaAdult Lymphocyte Predominant Hodgkin LymphomaAdult Mixed Cellularity Hodgkin LymphomaAdult Nasal Type Extranodal NK/T-cell LymphomaAdult Nodular Sclerosis Hodgkin LymphomaAnaplastic Large Cell LymphomaAngioimmunoblastic T-cell LymphomaHepatosplenic T-cell LymphomaNoncutaneous Extranodal LymphomaPeripheral T-cell LymphomaRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Hodgkin LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeT-cell Adult Acute Lymphoblastic LeukemiaT-cell Large Granular Lymphocyte Leukemia

Interventions

6,8-bis(benzylthio)octanoic acid

DRUG

bendamustine hydrochloride

DRUG

Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

NCT00082966

Adult Lymphocyte Depletion Hodgkin LymphomaAdult Mixed Cellularity Hodgkin Lymphoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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