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Use and Tolerability of Imatinib Mesylate (Gleevec) in Leukemia Patients

NCT00386373 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-08-01

No results posted yet for this study

Summary

Primary Objective:

1\. To assess the safety and toxicity of imatinib mesylate when given to patients with Ph (+) CML , ALL or AML within the first 100 days following allogeneic bone marrow or stem cell transplantation.

Secondary Objectives:

1. To identify any clinically significant drug interactions with imatinib in the post-transplant setting.
2. To develop specific monitoring parameters for imatinib use when utilized in the early post-BMT setting.
3. To record one-year survival data in this patient cohort to assess any effect of early imatinib administration on this endpoint.

Conditions

Interventions

DRUG

Imatinib Mesylate

Starting dose of 100 mg daily by mouth for first 100 days following bone marrow transplant (BMT) or stem cell transplant (SCT).

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Paolo Anderlini, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

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Entities

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 NCT00386373 on ClinicalTrials.gov