Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Trial Purpose and Description
RATIONALE: Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.
PURPOSE: This research study is developing a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia.
- To provide a risk-based classification system based on clinical, pathological, molecular, and early response data that will be used to assign all patients with newly diagnosed acute lymphoblastic leukemia (ALL) to the Children's Oncology Group (COG) frontline specific-treatment studies.
- To capture classification data for correlative studies accompanying current COG ALL treatment protocols.
- To provide a central reference guide for all required and research studies that will be conducted in local and reference laboratories for all newly diagnosed ALL patients.
- To provide a mechanism for optional banking of leukemia and germline specimens for current and future research.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (B-cell precursor vs infant vs T-cell acute lymphoblastic leukemia [ALL]).
Patients undergo blood sample collection and bone marrow biopsies at baseline and during and after induction therapy for immunophenotyping for ALL confirmation and classification, DNA ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies 4+10, and molecular testing for translocations) analysis by flow cytometry and FISH. Immunophenotype results obtained on this study are used to determine patient's assignment to specific clinical-trial treatments.
Some samples (leukemic and germline) may be banked for current and/or future analyses.
- Up to 30 Years
- Newly diagnosed acute leukemia meeting 1 of the following criteria:
- = 25% blasts by bone marrow aspirate
- Acute leukemia diagnosed by bone marrow biopsy
- Complete blood count with documented leukemia blasts of = 1,000/3L
- Patients with suspected acute lymphoblastic leukemia (ALL) who have true biphenotypic
or bilineage leukemia (i.e., patient with significant blasts expression of multiple
lymphoid and myeloid markers that cannot be assignment to a single lineage) are
allowed to enroll in AALL08B1 cell banking
- No patients with blast-myeloid morphology or whose blasts are myeloperoxidase
- Patients with high-risk or very high-risk disease may enroll in AALL1131
- No secondary ALL
- Not specified
PRIOR CONCURRENT THERAPY:
- No prior cytotoxic therapy
- Prior steroids or intrathecal chemotherapy allowed
- Children's Oncology Group
- National Cancer Institute (NCI)
- August 2010
- Last Updated:
- October 27, 2011
- Study HIC#:
Clinicaltrials.gov ID: NCT01142427