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

Completed · Phase 3

Conditions studied: Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT00075725

Run by

Children's Oncology Group

People needed

3154

Starts

2003-12-29

Expected to finish

2021-03-31

Last updated by the study team

2021-04-27

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients with Down syndrome are ineligible to enroll onto this study

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• USA Health Strada Patient Care Center — Mobile, Alabama, United States
• Banner Children's at Desert — Mesa, Arizona, United States
• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente Downey Medical Center — Downey, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Mattel Children's Hospital UCLA — Los Angeles, California, United States
• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.