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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief 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 Summary:

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.

Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • RR, derived from the modified IWG criteria and the International Cutaneous Lymphoma (Olsen criteria) for cutaneous lymphoma [ Time Frame: Up to 3 years ]
    RR and its 95% confidence interval will be assessed. RR and the possible correlation between RR and DCR vs. OS and PFS will be evaluated.
  • DCR, derived from the modified IWG criteria and the International Cutaneous Lymphoma (Olsen criteria) for cutaneous lymphoma [ Time Frame: Up to 3 years ]
    DCR and its 95% confidence interval will be assessed. DCR and the possible correlation between RR and DCR vs. OS and PFS will be evaluated.
  • OS [ Time Frame: Time from first dose of 6,8-bis(benzylthio)octanoic acid to death by any cause, assessed up to 3 years ]
    OS curves will be plotted using Kaplan-Meier methods. OS and the possible correlation between RR and DCR vs. OS and PFS will be evaluated.
  • PFS [ Time Frame: Time from first dose of 6,8-bis(benzylthio)octanoic acid to disease progression, assessed up to 3 years ]
    PFS curves will be plotted using Kaplan-Meier methods and median PFS will be examined. PFS and the possible correlation between RR and DCR vs. OS and PFS will be evaluated.
  • Bone marrow biopsy assessment [ Time Frame: After course 6 (168 days) ]
    Bone marrow and possible correlation between CR vs. bone marrow biopsy assessments such as clear of infiltration of leukemic cells according to morphology, and/or negative on leukemic cells according to immunohistochemistry will be evaluated.


Original Secondary Outcome: Same as current

Information By: Wake Forest University Health Sciences

Dates:
Date Received: June 18, 2014
Date Started: September 2014
Date Completion:
Last Updated: March 13, 2017
Last Verified: March 2017