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 — DRUG
    375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.
  • bortezomib — DRUG
    1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.
  • cladribine — DRUG
    4 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)

FacilityCityStateZIPSite coordinators
The University of Arizona Cancer CenterTucsonArizona85724-5024-

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