Trial Information

Molecular Genetic Features of Acute Lymphoblastic Leukemia

OBJECTIVES:

- Perform quantitative polymerase chain reaction (PCR) using known leukemia specific
markers in diagnostic bone marrow specimens and correlate pre-treatment copy number
with other biologic and molecular features, clinical response, and treatment outcomes
of patients with previously untreated acute lymphoblastic leukemia (ALL) or acute
promyelocytic leukemia (APL).

- Evaluate the expression of novel genes or microRNAs implicated in disease pathogenesis
and treatment response in pretreatment blood and bone marrow specimens of these
patients and correlate these findings with other biological features and treatment
outcome.

- Evaluate the clinical significance of sequential quantitative MRD measurements using
real-time quantitative PCR and/or flow cytometry during and following treatment and
correlate these findings with efficacy of novel treatment approaches and other
biological and clinical prognostic features.

- Compare the measurement of MRD in blood with bone marrow specimens in sequential
remission specimens.

OUTLINE: Blood and bone marrow samples are collected from patients periodically.

Samples are examined for the p190 and p210 BCR-ABL and WT-1 transcripts using reverse
transcriptase-polymerase chain reaction (RT-PCR) analysis of the DNA and for marginal
residual disease (MRD) via flow cytometric analysis.

Patients do not receive the results of the genetic testing and the results do not influence
the type or duration of treatment.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study over 5 years.