Biomarkers to Classify Young Patients With Acute Lymphoblastic Leukemia (ALL) and Remission Induction Therapy in Young Patients With B-Precursor ALL
RATIONALE: Studying samples of blood or bone marrow from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This trial is studying biomarkers to classify young patients with acute lymphoblastic leukemia (ALL) and remission induction therapy in young patients with B-precursor ALL.
|Leukemia||Drug: SC-PEG E. coli L-asparaginase Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: vincristine sulfate|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||ALinC 17, Classification ©), B-precursor Induction Treatment (I)|
- Collection of the clinical and laboratory data necessary for placing patients with acute lymphoblastic leukemia (ALL) onto the proper therapeutic trial (Classification)
- Creation of an administrative base to capture classification data for correlative studies in ALL treatment protocols and series of historical protocols (Classification)
- Creation of appropriate induction regimens for patients (Induction therapy)
- Correlation between event-free survival and measures of minimal-residual disease/early response
|Study Start Date:||December 1999|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
Experimental: Stratum 3
Patients receive oral dexamethasone twice daily on days 1-28; vincristine sulfate IV on days 1, 8, 15, and 22; pegaspargase intramuscularly (IM) on day 4, 5, or 6; cytarabine intrathecally (IT) on day 1; and methotrexate IT on day 8 (some patients also receive methotrexate IT on days 15 and 22).
Given ITDrug: dexamethasone
Given orallyDrug: methotrexate
Given ITDrug: pegaspargase
Given IMDrug: vincristine sulfate
Experimental: Stratum 4
Patients receive oral prednisone twice daily on days 1-28; vincristine sulfate IV on days 1, 8, 15, and 22; IM SC-PEG E. coli asparaginase on days 2, 5, 8, 12, 15, and 19; daunorubicin hydrochloride IV over 15-20 minutes on days 8, 15, and 22; and methotrexate IT on days 1 and 8 (some patients also receive methotrexate IT on days 15 and 22).
Drug: SC-PEG E. coli L-asparaginase
Given IMDrug: cytarabine
Given ITDrug: daunorubicin hydrochloride
Given IVDrug: methotrexate
Given ITDrug: prednisone
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225874
|Study Chair:||Dale J. Pullen, MD||University of Mississippi Cancer Clinic|