CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 14
Summary
- Conditions
- Adult Nodular Sclerosis Hodgkin Lymphoma
- Adult Lymphocyte Depletion Hodgkin Lymphoma
- Adult Lymphocyte Predominant Hodgkin Lymphoma
- Adult Mixed Cellularity Hodgkin Lymphoma
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T Cell Lymphoma
- Hepatosplenic T Cell Lymphoma
- Noncutaneous Extranodal Lymphoma
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Peripheral T Cell Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- T-cell Large Granular Lymphocyte Leukemia
- Recurrent Adult Acute Lymphoblastic Leukemia
- T-cell Adult Acute Lymphoblastic Leukemia
- Type
- Interventional
- Phase
- Phase 1
- 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: 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 ...
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.
Tracking Information
- NCT #
- NCT02168140
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Rakhee Vaidya Wake Forest University Health Sciences
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