drugset / Trial / NCT01439750
Bortezomib (VELCADE), Cladribine and Rituximab (VCR) in Mantle Cell Lymphoma (PSHCI 10-011)
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2012-05
- Primary completion
- 2018-08
- Completion
- 2020-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.6 mg/m2 | Subcutaneous |
| Subject | Cladribine | Small molecule | 3 mg/m2 | — |
| Subject | Cladribine | Small molecule | 4 mg/m2 | — |
| Subject | Cladribine | Small molecule | 5 mg/m2 | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |