Bortezomib, Cladribine, and Rituximab in Treating Patients With Advanced Mantle Cell Lymphoma or Indolent Lymphoma
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- University of Arizona
- Study ID
- NCT00980395
- Phase
- PHASE2
- Status
- Completed
Conditions
- Indolent Lymphoma
- Lymphoma
- Mantle Cell Lymphoma
- SLL
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- rituximab — DRUG375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.
- bortezomib — DRUG1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.
- cladribine — DRUG4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.
Study Details
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with cladribine and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with cladribine and rituximab works in treating patients with advanced mantle cell lymphoma or indolent lymphoma.
Key Dates
- Start date
- Jul 7, 2009
- Status verified
- Dec 2019
- Primary completion
- Sep 12, 2014
- Completion
- Aug 14, 2018
Study Design
- Enrollment
- 24 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: VCR (Velcade, Cladribine and Rituximab)* Rituximab 375 mg/m2 IV day1 * Cladribine 4 mg/m2 IV over 2 hours days 1-5 * Bortezomib 1.3 mg/m2 IV days 1 and 4 * Repeat every 28 days for a maximum of 6 cycles
Primary Outcome Measure
Progression-free Survival at 2 Years [ Time Frame: 2 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Arizona Cancer Center | Tucson | Arizona | 85724-5024 | - |
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