Brief Title
Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia
Official Title
Molecular Genetic Features of Acute Leukemia
Brief Summary
This research trial studies molecular genetic features in blood and tissue samples from patients with newly diagnosed acute lymphoblastic leukemia or acute promyelocytic leukemia. Studying samples of blood and tissue from patients with acute lymphoblastic leukemia or acute promyelocytic leukemia in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Detailed Description
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.
Study Type
Observational
Primary Outcome
Disease-free survival
Secondary Outcome
Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL
Condition
Leukemia
Intervention
laboratory biomarker analysis
Study Arms / Comparison Groups
Ancillary-Correlative (molecular genetic features)
Description: Previously collected blood and tissue samples are analyzed via RT-PCR and flow cytometry.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
840
Start Date
April 1999
Primary Completion Date
January 2100
Eligibility Criteria
- 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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Wendy Stock, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00003861
Organization ID
CALGB-9862
Secondary IDs
U10CA076001
Responsible Party
Sponsor
Study Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Wendy Stock, MD, Study Chair, University of Chicago
Verification Date
August 2021