Rituximab, Pentostatin, Cyclophosphamide, and Lenalidomide in Treating Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT00602836
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — BIOLOGICAL
    Cycle 1: 100 mg by IV on day 1, 375 mg/m\^2 by IV on day 2 Cycle 2-6: 375 mg/m\^2 by IV on day 1 (every 21 days)
  • Cyclophosphamide — DRUG
    600 mg/m\^2 by IV on day 1 of cycles 1-6 (every 21 days)
  • Lenalidomide — DRUG
    Cycle 7: 5 mg orally daily on days 1-28 Cycle 8: 10 mg orally daily on days 1-28 as tolerability permits Cycle 9 and beyond: 10 mg orally daily on days 1-28
  • Pentostatin — DRUG
    2 mg/m\^2 by IV on day 1 of cycles 1-6 (every 21 days)

Study Details

RATIONALE: 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. 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. Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and lenalidomide may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with pentostatin, cyclophosphamide, and lenalidomide works in treating patients with previously untreated B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.

Key Dates

Start date
Feb 29, 2008
Status verified
Sep 2017
Primary completion
Dec 31, 2010
Completion
Sep 12, 2017

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PCR-Lenalidomide
    Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide

Primary Outcome Measure

Number of Participants With Complete Response (CR) [ Time Frame: 12 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic ScottsdaleScottsdaleArizona85259-5499-
Mayo Clinic - JacksonvilleJacksonvilleFlorida32224-
Mayo Clinic Cancer CenterRochesterMinnesota55905-

Find similar trials in Scottsdale, AZ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Mayo Clinic Scottsdale· Scottsdale, AZMayo Clinic - Jacksonville· Jacksonville, FLMayo Clinic Cancer Center· Rochester, MN

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