drugset / Trial / NCT00003437
Hormone Therapy Plus Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia
RandomizedTreatment
Summary
RATIONALE: Hormone therapy may stop the growth of cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more cancer cells. It is not yet known which hormone therapy and chemotherapy regimen is most effective for acute lymphoblastic leukemia. PURPOSE: Randomized phase III trial to compare the effectiveness of different steroid therapy and chemotherapy regimens in treating children who have acute lymphoblastic leukemia.
Timeline
- Start
- 1997-01
- Primary completion
- —
- Completion
- —
Publications
- Background Krishnan S, Wade R, Moorman AV, Mitchell C, Kinsey SE, Eden TO, Parker C, Vora A, Richards S, Saha V. Temporal changes in the incidence and pattern of central nervous system relapses in children with acute lymphoblastic leukaemia treated on four consecutive Medical Research Council trials, 1985-2001. Leukemia. 2010 Feb;24(2):450-9. doi: 10.1038/leu.2009.264. Epub 2009 Dec 17.
- Background Mitchell C, Payne J, Wade R, Vora A, Kinsey S, Richards S, Eden T. The impact of risk stratification by early bone-marrow response in childhood lymphoblastic leukaemia: results from the United Kingdom Medical Research Council trial ALL97 and ALL97/99. Br J Haematol. 2009 Aug;146(4):424-36. doi: 10.1111/j.1365-2141.2009.07769.x. Epub 2009 Jun 22.
- Background Ramanujachar R, Richards S, Hann I, Goldstone A, Mitchell C, Vora A, Rowe J, Webb D. Adolescents with acute lymphoblastic leukaemia: outcome on UK national paediatric (ALL97) and adult (UKALLXII/E2993) trials. Pediatr Blood Cancer. 2007 Mar;48(3):254-61. doi: 10.1002/pbc.20749.
- Background Vora A, Ward R, Payne J, et al.: Benefit of targeted intensification for NCI high risk childhood lymphoblastic leukaemia: results of the United Kingdom Medical Research Council trial ALL97 and ALL97/99. [Abstract] Blood 108 (11): A-1869, 2006.
- Background Little MA, Morland B, Chisholm J, Hole A, Shankar A, Devine T, Easlea D, Meyer LC, Pinkerton CR. A randomised study of prophylactic G-CSF following MRC UKALL XI intensification regimen in childhood ALL and T-NHL. Med Pediatr Oncol. 2002 Feb;38(2):98-103. doi: 10.1002/mpo.1279.
- Results Ensor HM, Schwab C, Russell LJ, Richards SM, Morrison H, Masic D, Jones L, Kinsey SE, Vora AJ, Mitchell CD, Harrison CJ, Moorman AV. Demographic, clinical, and outcome features of children with acute lymphoblastic leukemia and CRLF2 deregulation: results from the MRC ALL97 clinical trial. Blood. 2011 Feb 17;117(7):2129-36. doi: 10.1182/blood-2010-07-297135. Epub 2010 Nov 24.
- Results Moorman AV, Ensor HM, Chilton L, et al.: Prognostic relevance of cytogenetics in childhood acute lymphoblastic leukaemia (ALL): final results from MRC ALL97. [Abstract] Blood 114 (22): A-88, 2009.
- Results Mitchell CD, Richards SM, Kinsey SE, Lilleyman J, Vora A, Eden TO; Medical Research Council Childhood Leukaemia Working Party. Benefit of dexamethasone compared with prednisolone for childhood acute lymphoblastic leukaemia: results of the UK Medical Research Council ALL97 randomized trial. Br J Haematol. 2005 Jun;129(6):734-45. doi: 10.1111/j.1365-2141.2005.05509.x.
- Results Roy A, Bradburn M, Moorman AV, Burrett J, Love S, Kinsey SE, Mitchell C, Vora A, Eden T, Lilleyman JS, Hann I, Saha V; Medical Research Council Childhood Leukaemia Working Party. Early response to induction is predictive of survival in childhood Philadelphia chromosome positive acute lymphoblastic leukaemia: results of the Medical Research Council ALL 97 trial. Br J Haematol. 2005 Apr;129(1):35-44. doi: 10.1111/j.1365-2141.2005.05425.x.
- Results Somervaille TC, Hann IM, Harrison G, Eden TO, Gibson BE, Hill FG, Mitchell C, Kinsey SE, Vora AJ, Lilleyman JS; MRC Childhood Leukaemia Working Party. Intraocular relapse of childhood acute lymphoblastic leukaemia. Br J Haematol. 2003 Apr;121(2):280-8. doi: 10.1046/j.1365-2141.2003.04280.x.
- Results Wallace AM, Tucker P, Williams DM, Hughes IA, Ahmed SF. Short-term effects of prednisolone and dexamethasone on circulating concentrations of leptin and sex hormone-binding globulin in children being treated for acute lymphoblastic leukaemia. Clin Endocrinol (Oxf). 2003 Jun;58(6):770-6. doi: 10.1046/j.1365-2265.2003.01790.x.
- Results Ahmed SF, Tucker P, Mushtaq T, Wallace AM, Williams DM, Hughes IA. Short-term effects on linear growth and bone turnover in children randomized to receive prednisolone or dexamethasone. Clin Endocrinol (Oxf). 2002 Aug;57(2):185-91. doi: 10.1046/j.1365-2265.2002.01580.x.
- Results Lancaster DL, Patel N, Lennard L, Lilleyman JS. Leucocyte versus erythrocyte thioguanine nucleotide concentrations in children taking thiopurines for acute lymphoblastic leukaemia. Cancer Chemother Pharmacol. 2002 Jul;50(1):33-6. doi: 10.1007/s00280-002-0442-6. Epub 2002 Apr 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 6.5 mg/m2 | Oral |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Subject | Prednisolone | Other / unclassified | 40 mg/m2 | Oral |
| Subject | Thioguanine | Small molecule | — | Oral |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intrathecal |
| Background | Daunorubicin | Small molecule | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Pegaspargase | Protein / enzyme biologic | — | Intramuscular |
| Background | Vincristine | Small molecule | — | Intravenous |
| Background | asparaginase | Protein / enzyme biologic | — | Intramuscular |