at San Francisco, California and other locations
study started



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



  • 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.


Leukemia, chronic myelogenous leukemia, DNA analysis, Southern blotting, cytogenetic analysis, polymerase chain reaction


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


  • 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


in progress, not accepting new patients
Start Date
Alliance for Clinical Trials in Oncology
Study Type
Expecting 60 study participants
Last Updated