Biomarkers to Classify Young Patients With Acute Lymphoblastic Leukemia (ALL) and Remission Induction Therapy in Young Patients With B-Precursor ALL
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|ClinicalTrials.gov Identifier: NCT01225874|
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : February 23, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: SC-PEG E. coli L-asparaginase Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: vincristine sulfate||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3762 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ALinC 17, Classification ©), B-precursor Induction Treatment (I)|
|Study Start Date :||December 1999|
|Actual Primary Completion Date :||March 2006|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225874
|Study Chair:||Dale J. Pullen, MD||University of Mississippi Cancer Clinic|