Hormone Therapy Plus Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia

NCT00003437 | Unknown Phase 3

• 3 other identifiers: CDR0000066464MRC-LEUK-ALL97EU-97032
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia

Keywords

recurrent childhood acute lymphoblastic leukemia; untreated childhood acute lymphoblastic leukemia

Interventions

asparaginase DRUG

cyclophosphamide DRUG

cytarabine DRUG

daunorubicin hydrochloride DRUG

dexamethasone DRUG

doxorubicin hydrochloride DRUG

mercaptopurine DRUG

methotrexate DRUG

pegaspargase DRUG

prednisolone DRUG

thioguanine DRUG

vincristine sulfate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed acute lymphoblastic leukemia (ALL) * No B-ALL (Burkitt-like, t(8;14), L3 morphology, SMIg positive) * Meets criteria for one of the following risk groups: * Standard risk * 1 to 9 years old * Highest WBC less than 50,000/mm\^3 * BCR-ABL negative * Not hypodiploid * No MLL gene rearrangements if 12 to 24 months old * Intermediate risk * Over 10 years old AND/OR * WBC greater than 50,000/mm\^3 * BCR-ABL negative * Not hypodiploid * No MLL gene rearrangement if 12 to 24 months old * High risk, defined by at least 1 of the following: * Slow early response with regimen A or B * BCR-ABL positive * Hypodiploid * MLL gene rearrangement and 12 to 24 months old PATIENT CHARACTERISTICS: Age: * 1 to 18 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Not specified Renal: * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * Previous treatment with HR1 regimens allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical Research Council: lead

Study Sites (1)

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Related Publications (13)

• 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.

  PMID: 20016529 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.

  PMID: 19549269 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.

  PMID: 16421910 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.

  PMID: 11813173 BACKGROUND

• 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.

  PMID: 21106984 RESULT

• 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.

  RESULT

• 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.

  PMID: 15952999 RESULT

• 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.

  PMID: 15801953 RESULT

• 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.

  PMID: 12694250 RESULT

• 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.

  PMID: 12780755 RESULT

• 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.

  PMID: 12153596 RESULT

• 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.

  PMID: 12111109 RESULT

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Doxorubicin; Mercaptopurine; Methotrexate; pegaspargase; Prednisolone; Thioguanine; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Sulfhydryl Compounds; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aminopterin; Pterins; Pteridines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Therapeutics

Study Officials

• C. Mitchell

  Oxford University Hospitals NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: January 1, 1997
• Last Updated: December 4, 2013

Record last verified: 2003-02

Locations

GB (1)