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Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL)

NCT00899431 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-01-27

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Lenalidomide

Starting dose 5 mg by mouth every other day; increase to 5 mg/d daily in 4-5 weeks for 6 - 12 months

DRUG

Fludarabine

30 mg/m\^2 intravenously daily on days -5, -4, -3.

DRUG

Rituximab

375 mg/m2 intravenously on day -13, and 1000 mg/m\^2 on days -6, +1 and +8.

DRUG

Thymoglobulin

1.0 mg/kg intravenously over 4 hours (day -2 and -1).

PROCEDURE

Stem Cell Transplantation

On Day 0, donor blood stem cells collected will be transplanted over 30-45 minutes.

DRUG

Bendamustine

130 mg/m2/day by vein daily on day -5, -4, -3 (following Fludarabine).

DRUG

Allopurinol

300 mg by mouth daily beginning at the start of lenalidomide therapy and continuing for 3 months.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Issa F. Khouri, MD, BS · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-06
Primary Completion
2018-10-07
Completion
2018-10-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00899431 on ClinicalTrials.gov