Lenalidomide and Rituximab as Treatment of Chronic Lymphocytic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00759603
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide — DRUG
    Started on Day 9 of Cycle 1 at the dose of 10 mg/day and continued daily. Treatment duration will be twelve cycles.
  • Rituximab — DRUG
    Dose of 375 mg/m\^2 given intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2.

Study Details

The goal of this clinical research study is to learn if the combination of lenalidomide and rituximab can help to control Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) in patients who have already received therapy. The safety of this drug combination will also be studied.

Key Dates

Start date
Sep 30, 2008
Status verified
Jul 2015
Primary completion
Jul 31, 2014
Completion
Jul 31, 2014

Study Design

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

Arms

  • Experimental: Lenalidomide + Rituximab
    Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m\^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.

Primary Outcome Measure

Overall Participant Response Rate: Percentage of Participants With Complete + Partial Response According to Revised National Cancer Institute-sponsored Working Group Guidelines [ Time Frame: Responses assessed after 12 cycles, up to 48 weeks with interim assessments performed after 3, 6 and 12 cycles. ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
The University of Texas M.D. Anderson Cancer Center· Houston, TX

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