Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00899431
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide — DRUG
    Starting dose 5 mg by mouth every other day; increase to 5 mg/d daily in 4-5 weeks for 6 - 12 months
  • Fludarabine — DRUG
    30 mg/m\^2 intravenously daily on days -5, -4, -3.
  • Rituximab — DRUG
    375 mg/m2 intravenously on day -13, and 1000 mg/m\^2 on days -6, +1 and +8.
  • Thymoglobulin — DRUG
    1.0 mg/kg intravenously over 4 hours (day -2 and -1).
  • Stem Cell Transplantation — PROCEDURE
    On Day 0, donor blood stem cells collected will be transplanted over 30-45 minutes.
  • Bendamustine — DRUG
    130 mg/m2/day by vein daily on day -5, -4, -3 (following Fludarabine).
  • Allopurinol — DRUG
    300 mg by mouth daily beginning at the start of lenalidomide therapy and continuing for 3 months.

Study Details

The goal of this clinical research study is to learn if lenalidomide, when given with a stem cell transplant and chemotherapy (bendamustine, fludarabine, and rituximab), can help to control CLL. The safety of this treatment combination will also be studied.

Key Dates

Start date
May 6, 2009
Status verified
Jan 2020
Primary completion
Oct 7, 2018
Completion
Oct 7, 2018

Study Design

Enrollment
39 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group 1: Lenalidomide
    Chemotherapy, Plus Lenalidomide - Lenalidomide starting dose 5 mg by mouth every other day; increase to 5 mg/d daily in 4-5 weeks for 6 - 12 months. Fludarabine 30 mg/m\^2 intravenously daily on days -5, -4, -3. Rituximab 375 mg/m2 intravenously on day -13, and 1000 mg/m\^2 on days -6, +1 and +8. Thymoglobulin 1.0 mg/kg intravenously over 4 hours (day -2 and -1). On Day 0, donor blood stem cells collected will be transplanted over 30-45 minutes. Bendamustine 130 mg/m2/day by vein daily on day -5, -4, -3 (following Fludarabine). Allopurinol 300 mg by mouth daily beginning at the start of lenalidomide therapy and continuing for 3 months.
  • Active Comparator: Group 2: No Lenalidomide
    Chemotherapy Treatment, No Lenalidomide - Fludarabine 30 mg/m\^2 intravenously daily on days -5, -4, -3. Rituximab 375 mg/m2 intravenously on day -13, and 1000 mg/m\^2 on days -6, +1 and +8. Thymoglobulin 1.0 mg/kg intravenously over 4 hours (day -2 and -1). On Day 0, donor blood stem cells collected will be transplanted over 30-45 minutes. Bendamustine 130 mg/m2/day by vein daily on day -5, -4, -3 (following Fludarabine).

Primary Outcome Measure

Immunomanipulation After Non-myeloablative Stem Cell Transplantation for CLL (Chronic Lymphocytic Leukemia). [ Time Frame: Up to 18 months after allotransplant. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
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By specialty
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By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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