Bortezomib (VELCADE), Cladribine and Rituximab (VCR) in Mantle Cell Lymphoma (PSHCI 10-011)
Status:
Unknown status
Trial end date:
2020-08-01
Target enrollment:
Participant gender:
Summary
This is a phase I/II trial of bortezomib, cladribine, and rituximab in newly diagnosed and
relapsed mantle cell lymphoma (MCL). The phase I component has three dose levels of
cladribine (3 mg/m2, 4 mg/m2, and 5 mg/m2) and is designed as a traditional dose-escalation
study in which cohorts of 3 patients are evaluated for the incidence of dose-liming toxicity
(DLT) at each dose level. Once the maximum tolerated dose (MTD) is determined, a phase II
component with 2 arms will begin. One arm will enroll newly diagnosed MCL patients and one
arm will enroll relapsed MCL patients. Each arm is a single-stage, fixed sample size study
and will be accrued and analyzed separately. The phase I and II data will also be analyzed
separately.