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Hormone Therapy Plus Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003437
First received: November 1, 1999
Last updated: April 13, 2011
Last verified: February 2003
History of Changes
  Purpose

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.


Condition Intervention Phase
Leukemia
 Drug: 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
Radiation: radiation therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Medical Research Council Working Party on Leukaemia in Children UK National Lymphoblastic Leukaemia (ALL) Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1800
Study Start Date: January 1997
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003437

Locations
United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Sponsors and Collaborators
Medical Research Council
Investigators
Study Chair: C. Mitchell Oxford Radcliffe Hospital
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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.
Mitchell CD, Richards SM, Kinsey SE, et al.: Benefit of dexamethasone compared with prednisolone for childhood acute lymphoblastic leukaemia: results of UK MRC trial ALL97/99. [Abstract] Pediatr Blood Cancer 43 (4): A-0.082, 2004.
Roy A, Bradburn M, Moorman AV, et al.: 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. [Abstract] Blood 104 (11): A-165, 2004.
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.

ClinicalTrials.gov Identifier: NCT00003437     History of Changes
Other Study ID Numbers: CDR0000066464, MRC-LEUK-ALL97, EU-97032
Study First Received: November 1, 1999
Last Updated: April 13, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Cytarabine
Methotrexate
Thioguanine
Cyclophosphamide
Pegaspargase
 Asparaginase
Daunorubicin
Dexamethasone
Doxorubicin
Prednisolone
Methylprednisolone Hemisuccinate
Vincristine
BB 1101
Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Dexamethasone 21-phosphate
Prednisolone hemisuccinate
Prednisolone phosphate

ClinicalTrials.gov processed this record on May 16, 2013