Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Phase I Dose-Escalation Study of CPI-613, in Combination With Bendamustine and Rituximab, in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
This phase I trial studies the side effects and best dose of CPI-613 (6,8-bis[benzylthio]octanoic acid) when given together with bendamustine hydrochloride and rituximab in treating patients with B-cell non-Hodgkin lymphoma that has come back or has not responded to treatment. Drugs used in chemotherapy, such as 6,8-bis(benzylthio)octanoic acid and 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. Monoclonal antibodies, such as rituximab, may find cancer cells and help kill them. Giving 6,8-bis(benzylthio)octanoic acid with bendamustine hydrochloride and rituximab may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of CPI-613, when used in combination with
bendamustine (bendamustine hydrochloride) and rituximab in patients with relapsed or
refractory B-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.
II. To evaluate overall survival (OS) and progression-free-survival (PFS), and possible
correlation between RR and DCR derived from the modified IWG 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 accordingly to morphology, and/or negative on leukemic cells according to
immunohistochemistry).
IV. To evaluate safety of the CPI-613 + bendamustine + rituximab 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
(week 1) and days 1 and 4 (weeks 2 and 3). Patients also receive bendamustine hydrochloride
IV over 30 minutes on days 4 and 5 and rituximab on day 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.
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