Study of Blood and Bone Marrow Samples in Patients With Chronic Myelogenous Leukemia Enrolled on a CALGB Clinical Trial

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:

- 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