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Imatinib Mesylate, Busulfan, Fludarabine, and Antithymocyte Globulin for CML Patients

NCT00499889 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2012-04-23

Study results available
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Summary

Primary Objective:

To estimate the probability of molecular complete remission at one year for the described sequential treatment approach, with nonablative hematopoietic transplantation, post transplant imatinib mesylate and donor lymphocyte infusion, in patients with Ph-positive Chronic Myelogenous Leukemia (CML) not in blastic transformation.

Secondary Objective:

Response to post transplant Imatinib mesylate therapy for 12 weeks as treatment of residual disease, response to donor lymphocyte infusion (DLI) for residual disease following imatinib mesylate therapy, as well as engraftment, toxicity, disease free survival and survival, effect of busulfan pharmacokinetics on study outcome.

Conditions

Interventions

DRUG

Imatinib Mesylate

400 mg by mouth twice daily for 9 Days

DRUG

Fludarabine (Fludara)

40 mg/m\^2 by vein daily for 4 Days

DRUG

Busulfan

130 mg/m\^2 by vein daily for 2 Days

DRUG

Antithymocyte Globulin (ATG)

2.5 mg/kg by vein daily for 3 Days

DRUG

Tacrolimus

Tacrolimus levels maintained between 5-15 ng/dl, first as continuous IV infusion, and converted to oral every 12 hour dosing as tolerated. Starting day -2 until day 180.

DRUG

Methotrexate

5 mg/m2 on days 1, 3, 6 and 11.

PROCEDURE

Donor lymphocyte infusion (DLI)

Infusion of lymphocytes from the original bone marrow donor by vein if relapse after \>4 weeks of imatinib.

PROCEDURE

Stem Cell Transplant

Infusion of donor bone marrow or blood stem cells by vein over approximately one hour on day 0.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Richard E. Champlin, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2009-11-30
Completion
2009-11-30

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 NCT00499889 on ClinicalTrials.gov