Hormone Therapy Plus Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia

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.

Sex

All

Minimum age

1 Year

Maximum age

18 Years

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

• BACKGROUNDKrishnan 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
• BACKGROUNDMitchell 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
• BACKGROUNDRamanujachar 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
• BACKGROUNDVora 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.
• BACKGROUNDLittle 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
• RESULTEnsor 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.