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

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Trial Information

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.

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


- Not specified


- Not specified

Type of Study:


Study Design:


Outcome Measure:

Distribution response as determined by both quantitative RT-PCR and Southern blot monitoring of blood samples periodically during treatment and then at 6-12 month intervals

Safety Issue:


Principal Investigator

Wendy Stock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

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



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Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Naval Medical Center - San Diego San Diego, California  92134-3202
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Mount Sinai Medical Center New York, New York  10029
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New York East Syracuse, New York  13057
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
University of Illinois Cancer Center Chicago, Illinois  60612-7243
CancerCare of Maine at Eastern Maine Medical Center Bangor, Maine  04401
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Veterans Affairs Medical Center - Chicago Westside Hospital Chicago, Illinois  60612
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana  46815
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Mountainview Medical Berlin, Vermont  05602
Danville Regional Medical Center Danville, Virginia  24541
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224-1791
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Union Hospital Cancer Program at Union Hospital Elkton MD, Maryland  21921
Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis, Missouri  63141
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240
Kinston Medical Specialists Kinston, North Carolina  28501
Comprehensive Cancer Care, PC Saint Louis, Missouri  63141