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.