drugset / Trial / NCT00165178
Treatment of Acute Lymphoblastic Leukemia in Children
Phase 3
Completed
498 enrolled
Dana-Farber Cancer Institute
Boston Children's Hospital · collabColumbia University · collabLaval University · collabMaine Children's Cancer Program · collabMcMaster University · collabOchsner Health System · collabSan Jorge Children's Hospital (Puerto Rico) · collabSt. Justine's Hospital · collabTulane University School of Medicine · collabUniversity of Rochester · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to reduce the side-effects from anti-leukemia therapy. The therapy in this study is based upon treatment information learned from prior clinical research programs as well as from laboratory research.
Timeline
- Start
- 2000-09
- Primary completion
- 2004-12
- Completion
- 2011-05
Publications
- Background Silverman LB, Gelber RD, Dalton VK, Asselin BL, Barr RD, Clavell LA, Hurwitz CA, Moghrabi A, Samson Y, Schorin MA, Arkin S, Declerck L, Cohen HJ, Sallan SE. Improved outcome for children with acute lymphoblastic leukemia: results of Dana-Farber Consortium Protocol 91-01. Blood. 2001 Mar 1;97(5):1211-8. doi: 10.1182/blood.v97.5.1211.
- Background Silverman LB, Declerck L, Gelber RD, Dalton VK, Asselin BL, Barr RD, Clavell LA, Hurwitz CA, Moghrabi A, Samson Y, Schorin MA, Lipton JM, Cohen HJ, Sallan SE. Results of Dana-Farber Cancer Institute Consortium protocols for children with newly diagnosed acute lymphoblastic leukemia (1981-1995). Leukemia. 2000 Dec;14(12):2247-56. doi: 10.1038/sj.leu.2401980.
- Background Goldberg JM, Silverman LB, Levy DE, Dalton VK, Gelber RD, Lehmann L, Cohen HJ, Sallan SE, Asselin BL. Childhood T-cell acute lymphoblastic leukemia: the Dana-Farber Cancer Institute acute lymphoblastic leukemia consortium experience. J Clin Oncol. 2003 Oct 1;21(19):3616-22. doi: 10.1200/JCO.2003.10.116.
- Background Lipshultz SE, Rifai N, Dalton VM, Levy DE, Silverman LB, Lipsitz SR, Colan SD, Asselin BL, Barr RD, Clavell LA, Hurwitz CA, Moghrabi A, Samson Y, Schorin MA, Gelber RD, Sallan SE. The effect of dexrazoxane on myocardial injury in doxorubicin-treated children with acute lymphoblastic leukemia. N Engl J Med. 2004 Jul 8;351(2):145-53. doi: 10.1056/NEJMoa035153.
- Vrooman LM, Stevenson KE, Supko JG, O'Brien J, Dahlberg SE, Asselin BL, Athale UH, Clavell LA, Kelly KM, Kutok JL, Laverdiere C, Lipshultz SE, Michon B, Schorin M, Relling MV, Cohen HJ, Neuberg DS, Sallan SE, Silverman LB. Postinduction dexamethasone and individualized dosing of Escherichia Coli L-asparaginase each improve outcome of children and adolescents with newly diagnosed acute lymphoblastic leukemia: results from a randomized study--Dana-Farber Cancer Institute ALL Consortium Protocol 00-01. J Clin Oncol. 2013 Mar 20;31(9):1202-10. doi: 10.1200/JCO.2012.43.2070. Epub 2013 Jan 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | — | Oral |
| Comparator | Prednisone | Other / unclassified | — | Oral |
| Background | asparaginase | Protein / enzyme biologic | 12500 unknown | Intramuscular |
| Background | asparaginase | Protein / enzyme biologic | 25000 unknown | Intramuscular |
| Background | Cytarabine | Small molecule | — | Intrathecal |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | Leucovorin | Small molecule | — | Intravenous |
| Background | Methotrexate | Small molecule | — | Intravenous |
| Background | Vincristine | Small molecule | — | Intravenous |
| Background | asparaginase | Protein / enzyme biologic | — | Intramuscular |