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


N/A
N/A
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

N/A

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:

No

Principal Investigator

Wendy Stock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

CDR0000078595

NCT ID:

NCT01004640

Start Date:

Completion Date:

Related Keywords:

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

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
University of Illinois Cancer CenterChicago, Illinois  60612-7243
CancerCare of Maine at Eastern Maine Medical CenterBangor, Maine  04401
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Veterans Affairs Medical Center - Chicago Westside HospitalChicago, Illinois  60612
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Mountainview MedicalBerlin, Vermont  05602
Danville Regional Medical CenterDanville, Virginia  24541
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Arch Medical Services, Incorporated at Center for Cancer Care and ResearchSaint Louis, Missouri  63141
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Kinston Medical SpecialistsKinston, North Carolina  28501
Comprehensive Cancer Care, PCSaint Louis, Missouri  63141