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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
Not Recruiting
Trial ID: NCT00075725
Purpose
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 see how well they work compared to methotrexate alone during
maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia
(ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and
leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop
growing or die. Giving more than one drug may kill more cancer cells. It is not yet known
which combination chemotherapy regimen is more effective in treating acute lymphoblastic
leukemia.
Official Title
High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- 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 Criteria:
- Patients with Down syndrome are ineligible to enroll onto this study
Intervention(s):
drug: vincristine sulfate
radiation: radiation therapy
drug: cyclophosphamide
drug: cytarabine
drug: daunorubicin hydrochloride
drug: dexamethasone
drug: doxorubicin hydrochloride
drug: leucovorin calcium
drug: mercaptopurine
drug: methotrexate
drug: pegaspargase
drug: prednisone
drug: thioguanine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535