drugset / Trial / NCT01230983
Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia or Advanced Lymphoblastic Non-Hodgkin's Lymphoma
Non-randomizedSingle-groupDouble-blindSupportive care
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Dexrazoxane may lessen the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without dexrazoxane and with or without high-dose methotrexate in patients with acute lymphoblastic leukemia or advanced lymphoblastic non-Hodgkin's lymphoma.
Timeline
- Start
- 1996-06
- Primary completion
- 2001-09
- Completion
- 2004-10
Publications
- Background Cleaver AL, Beesley AH, Firth MJ, Sturges NC, O'Leary RA, Hunger SP, Baker DL, Kees UR. Gene-based outcome prediction in multiple cohorts of pediatric T-cell acute lymphoblastic leukemia: a Children's Oncology Group study. Mol Cancer. 2010 May 12;9:105. doi: 10.1186/1476-4598-9-105.
- Background Salzer WL, Devidas M, Carroll WL, Winick N, Pullen J, Hunger SP, Camitta BA. Long-term results of the pediatric oncology group studies for childhood acute lymphoblastic leukemia 1984-2001: a report from the children's oncology group. Leukemia. 2010 Feb;24(2):355-70. doi: 10.1038/leu.2009.261. Epub 2009 Dec 17.
- Background Matloub Y, Asselin BL, Stork LC, et al.: Outcome of children with T-Cell acute lymphoblastic leukemia (T-ALL) and standard risk (SR) features: results of CCG-1952, CCG-1991 and POG 9404. [Abstract] Blood 104 (11): A-680, 195a, 2004.
- Background Seibel NL, Asselin BL, Nachman JB, et al.: Treatment of high risk T-cell acute lymphoblastic leukemia (T-ALL): comparison of recent experience of the Children's Cancer Group (CCG) and Pediatric Oncology Group (POG). [Abstract] Blood 104 (11): A-681, 2004.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexrazoxane | Small molecule | — | Intravenous |
| Comparator | Leucovorin | Small molecule | — | Intravenous |
| Subject | Methotrexate | Small molecule | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Background | Prednisone | Other / unclassified | — | Oral |
| Background | Vincristine | Small molecule | — | Intravenous |
| Background | asparaginase | Protein / enzyme biologic | — | Intravenous |