Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia

Objectives:

1. To perform quantitative PCR using known leukemia specific markers in diagnostic bone
marrow specimens of patients with newly diagnosed APL and ALL and to correlative
pre-treatment copy number with other biologic and molecular features, clinical response,
and treatment outcome.

2. To evaluate the expression of novel genes or microRNAs implicated in disease
pathogenesis and treatment response in pretreatment blood and bone marrow specimens of
patients with APL and ALL and to correlate expression level with other biological
features and treatment outcome.

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

4. To compare measurement of MRD in blood with bone marrow specimens in sequential
remission specimens of patients receiving treatment on ALL and APL treatment trials.

- Patients with a diagnosis of acute lymphoblastic leukemia (ALL) entered onto CALGB
treatment trials for previously untreated ALL must be enrolled on CALGB 9862. Entry on
CALGB 8461 is strongly encouraged.

- Patients with a diagnosis of acute promyelocytic leukemia (APL) enrolled on SWOG S0521
or S0535 must be enrolled on CALGB 9862.