Status:
COMPLETED
Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-30 years
Phase:
PHASE3
Brief Summary
This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to s...
Detailed Description
OBJECTIVES: I. Improve the outcome of children with high-risk acute lymphoblastic leukemia treated with 2 different chemotherapy regimens. II. Determine the relative safety and efficacy of dexametha...
Eligibility Criteria
Inclusion
- Must be eligible for and enrolled on classification study COG-AALL03B1
- Newly diagnosed B-precursor acute lymphoblastic leukemia
- WBC \> 50,000/mm\^3 for patients age 1 to 9
- Any WBC for patients age 10 to 30 OR patients who have received prior steroid therapy OR patients with testicular disease
- Whit blood cell (WBC) criteria:
- Age 1 - 9 years: WBC \>= 50,000/uL
- Age 10 - 30 years: any WBC
- Prior steroid therapy: any WBC
- Testicular disease: any WBC
- Patients shall have had no other prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine
- Patients receiving prior steroid therapy (as described in AALL03B1) are eligible for study; the dose and duration of previous steroid therapy should be carefully documented
- 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
Exclusion
- Patients with Down syndrome are ineligible to enroll onto this study
Key Trial Info
Start Date :
December 29 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
3154 Patients enrolled
Trial Details
Trial ID
NCT00075725
Start Date
December 29 2003
End Date
March 31 2021
Last Update
April 27 2021
Active Locations (234)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
3
USA Health Strada Patient Care Center
Mobile, Alabama, United States, 36604
4
Banner Children's at Desert
Mesa, Arizona, United States, 85202