Pentostatin, Cyclophosphamide, and Rituximab With or Without Bevacizumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT00816595
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    Given IV
  • pegfilgrastim — BIOLOGICAL
    Given subcutaneously
  • rituximab — BIOLOGICAL
    Given IV
  • cyclophosphamide — DRUG
    Given IV
  • pentostatin — DRUG
    Given IV

Study Details

RATIONALE: Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, 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 and bevacizumab, 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. It is not yet known whether giving pentostatin and cyclophosphamide together with rituximab is more effective with or without bevacizumab in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma. PURPOSE: This randomized phase II trial is studying the side effects of giving pentostatin and cyclophosphamide together with rituximab with or without bevacizumab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.

Key Dates

Start date
Feb 28, 2009
Status verified
May 2017
Primary completion
Jul 31, 2013
Completion
Nov 29, 2016

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin
    Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m\^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m\^3 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm B: Pentostatin, Cyclophosphamide, and Rituximab
    Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m\^2 on day 2 of course 1 and 375 mg/m\^2 on day 1 of courses 2-6. They receive 2 mg/m\^2 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Complete and Overall Response Rate [ Time Frame: Evaluated after 6 cycles (up to 196 days) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo ClinicRochesterMinnesota55905-

Find similar trials in Scottsdale, AZ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic· Rochester, MN

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