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Imatinib Mesylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Received Chemotherapy

NCT00509093 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-03-17

Study results available
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Summary

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with newly diagnosed acute myeloid leukemia who have received chemotherapy.

Conditions

Interventions

DRUG

imatinib mesylate

Patients will receive treatment with imatinib mesylate at a dose of 600 mg by mouth once a day for 12 months. The study dose can be split but the dose of 600 mg must be given within a 12 hour period.

GENETIC

gene expression analysis

Multidrug resistance genes: These studies will include: MDR1, MRP1, LRP, and BCRP. Bone marrow blocks or cut slides will be sent to Duke on the diagnostic AML samples. DNA will be eluted from the samples so that the above genes can be analyzed.

GENETIC

mutation analysis

FLT3 mutation analysis (on bone marrow aspirate or peripheral blood): These analyses will be performed by pathology at the time of diagnosis, at the participating institution. Samples will be analyzed for the FLT3 ITD and/or D835 mutation by PCR.

GENETIC

polymerase chain reaction

AF1q gene analysis (on bone marrow aspirate)

OTHER

flow cytometry

C-kit MFI on AML samples will be calculated by using a CD45/ orthogonal light scatter gate to isolate blasts. The MFI will be calculated as the c-kit mean channel number (MCN) of the blasts/ MCN auto fluorescence.

PROCEDURE

biopsy

Diagnostic bone marrow biopsy/aspirate must be done within 3 weeks of registration documenting complete remission

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Anjali Advani, MD · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  • Brenda Cooper, MD · University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2014-05-09
Completion
2015-04-09

Countries

  • United States

Study Locations

More Related Trials

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 NCT00509093 on ClinicalTrials.gov