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Summary

at San Francisco, California and other locations
study started

Description

Summary

RATIONALE: Studying samples of blood and bone marrow from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood and bone marrow samples in patients with chronic myelogenous leukemia enrolled on a CALGB clinical trial.

Official Title

Molecular and Cytogenetic Monitoring of CML - A Mandatory Companion to CALGB 19804

Details

OBJECTIVES:

  • Monitor molecular response rates of patients receiving treatment for chronic myelogenous leukemia by quantitative reverse transcription polymerase chain reaction (RT-PCR) and quantitative Southern blot monitoring of blood samples.
  • Compare quantitative RT-PCR and quantitative Southern blot results with marrow cytogenetics at the time of complete molecular response in these patients.
  • Monitor the frequency of residual disease in patients who achieve a complete blood Southern blot and marrow cytogenetic response (eradication of BCR/ABL by Southern blot and absence of the Philadelphia chromosome by cytogenetics).

OUTLINE: Peripheral blood samples and bone marrow aspirates are collected at baseline and at 3, 6, and 9 months after starting therapy. If patient continues to receive protocol treatment after 9 months, additional peripheral blood samples are collected every 6 months and bone marrow aspirates are taken annually. In the event of disease progression (blast crisis), an additional peripheral blood sample and bone marrow aspirate are collected.

Samples are examined by quantitative Southern blot analysis with probes to BCR, quantitative reverse transcriptase-polymerase chain reaction analysis for BCR/ABL fusion transcripts, and cytogenetic analysis.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1.5 years.

Keywords

Leukemia chronic myelogenous leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Eligibility

Inclusion Criteria:

  • Clinical diagnosis of chronic myelogenous leukemia (CML)
  • Concurrent enrollment on a CALGB treatment protocol for newly diagnosed or previously treated CML (e.g, CLB-19804)
  • Must not have initiated study therapy

Locations

  • UCSF Medical Center-Mount Zion
    San Francisco, California, 94115, United States
  • University Medical Center of Southern Nevada
    Las Vegas, Nevada, 89102, United States
  • CCOP - Nevada Cancer Research Foundation
    Las Vegas, Nevada, 89106, United States
  • Nevada Cancer Research Foundation CCOP
    Las Vegas, Nevada, 89106, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT01004640
Study Type
Observational
Last Updated
August 7, 2017