Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia
RATIONALE: Determination of genetic markers for acute lymphoblastic leukemia and acute promyelocytic leukemia may help identify patients with this disease and help predict the outcome of treatment.
PURPOSE: Diagnostic study of genetic markers in adult patients who have acute lymphoblastic leukemia or acute promyelocytic leukemia.
Genetic: reverse transcriptase-polymerase chain reaction
Other: flow cytometry
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||Molecular Genetic Features of Acute Lymphoblastic Leukemia|
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Association of novel genes or micorRNAs with other biomarkers [ Designated as safety issue: No ]
- Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL [ Designated as safety issue: No ]
- Clinical significance of MRD as defined by W T-1 [ Designated as safety issue: No ]
- Blood and bone marrow specimen comparison on the quantitative measurement of MRD [ Designated as safety issue: No ]
|Study Start Date:||April 1999|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003861
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|Study Chair:||Wendy Stock, MD||University of Chicago|