Clinical Trials (PDQ®)
|No phase specified||Health services research, Tissue collection/Repository||Active||30 and under||NCI, Other||AALL08B1|
NCI-2011-02235, CDR0000674844, COG-AALL08B1, U10CA098543, NCT01142427
This research study is developing a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia. Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.
Further Study Information
I. 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.
II. To capture classification data for correlative studies accompanying current COG ALL treatment protocols.
III. 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.
IV. 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, deoxyribonucleic acid (DNA) ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies 4+10, and molecular testing for translocations) analysis by flow cytometry and fluorescent in situ hybridization (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.
- Newly diagnosed acute leukemia meeting 1 of the following criteria:
- > 25% blasts by bone marrow (BM) aspirate
- If a BM aspirate is not obtained, the diagnosis of acute leukemia can be established by a pathologic diagnosis of acute leukemia on a BM biopsy
- A complete blood count (CBC) documenting the presence of at least 1,000/µL circulating leukemic blasts
- Adequate samples must be provided to the reference and/or Children's Oncology Group (COG)-approved cytogenetics laboratories to allow completion of the studies needed for risk-stratification
- 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 positive
- Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference Laboratory studies
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met
- Patient must not have received prior cytotoxic therapy except for steroids or intrathecal chemotherapy
- Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
Trial Lead Organizations/Sponsors
Children's Oncology GroupNational Cancer Institute
|Karen Rabin, MD||Principal Investigator|
|Saint Peter's University Hospital|
|Stanley Calderwood||Ph: 732-745-8600ext6163|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01142427
ClinicalTrials.gov processed this data on February 13, 2014
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