drugset / Trial / NCT00002961
Chemotherapy With or Without Total-Body Irradiation Prior to Bone Marrow Transplantation in Treating Children With Acute Lymphoblastic Leukemia
RandomizedTreatment
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy, radiation therapy, and bone marrow transplantation may kill more cancer cells. PURPOSE: Randomized phase III trial to compare high-dose chemotherapy with or without total-body irradiation before bone marrow transplantation in treating children with acute lymphoblastic leukemia.
Timeline
- Start
- 1995-10
- Primary completion
- 2001-02
- Completion
- 2001-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Busulfan | Small molecule | 0.8 mg/kg | Intravenous |
| Comparator | Busulfan | Small molecule | 1 mg/kg | Intravenous |
| Comparator | Busulfan | Small molecule | 1.25 mg/kg | Intravenous |
| Comparator | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 10 mg/kg | — |
| Comparator | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 100 mg/kg | — |
| Comparator | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 300 mg/m2 | — |
| Comparator | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Comparator | Cyclosporine | Peptide | 1.5 mg/kg | Intravenous |
| Comparator | Etoposide | Small molecule | 40 mg/kg | Intravenous |
| Comparator | Methotrexate | Small molecule | 10 mg/m2 | Intravenous |