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Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.

Sponsored by: Medical Research Council
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003436
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow doctors to give higher doses of chemotherapy and kill more cancer cells. It is not yet known whether chemotherapy is more effective with or without bone marrow transplantation for acute myeloid leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without bone marrow transplantation in treating children who have acute myeloid leukemia.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Drug: amsacrine
Drug: asparaginase
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: methotrexate
Drug: mitoxantrone hydrochloride
Drug: therapeutic hydrocortisone
Procedure: allogeneic bone marrow transplantation
Phase III

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Leukemia, Childhood   

ChemIDplus related topics:   Cytarabine    Cytarabine hydrochloride    Etoposide    L-Asparaginase    Daunorubicin hydrochloride    Daunorubicin    Hydrocortisone    Cortisol 21-phosphate    Cortisol succinate    Hydrocortamate    Hydrocortisone 21-sodium succinate    Hydrocortisone acetate    Hydrocortisone cypionate    Hydrocortisone hemisuccinate    Proctofoam-HC    Methotrexate    Mitoxantrone hydrochloride    Mitoxantrone    Etoposide phosphate    Amsacrine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
Official Title:   Medical Research Council Working Party on Leukaemia in Childhood Acute Myeloid Leukaemia Trial 12

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

Estimated Enrollment:   2000
Study Start Date:   July 1998

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • One of the following diagnoses:

    • Histologically confirmed de novo or secondary acute myeloid leukemia (AML)
    • Aggressive myelodysplastic syndromes (refractory anemia with excess blasts (RAEB) and RAEB in transformation) for which intensive AML therapy is considered appropriate
    • Acute promyelocytic leukemia (should also be entered into protocol MRC-ATRA)
  • No chronic myeloid leukemia in blast transformation
  • Must be considered suitable for intensive chemotherapy

PATIENT CHARACTERISTICS:

Age:

  • Under 16

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other concurrent active malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for leukemia

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003436

Locations
United Kingdom, England
Christie Hospital N.H.S. Trust    
      Manchester, England, United Kingdom, M20 4BX

Sponsors and Collaborators
Medical Research Council

Investigators
Study Chair:     Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F     Christie Hospital    
  More Information


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

Publications:
Gibson BE, Wheatley K, Hann IM, Stevens RF, Webb D, Hills RK, De Graaf SS, Harrison CJ. Treatment strategy and long-term results in paediatric patients treated in consecutive UK AML trials. Leukemia. 2005 Dec;19(12):2130-8.
 
Burnett AK, Hills RK, Goldstone AH, et al.: The impact of transplant in AML in 2nd CR: a prospective study of 741 in the MRC AML 10 and 12 trials. [Abstract] Blood 104 (11): A-620, 2004.
 

Study ID Numbers:   CDR0000066463, MRC-LEUK-AML12CH, EU-98010
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003436
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated childhood acute myeloid leukemia and other myeloid malignancies  
childhood acute promyelocytic leukemia (M3)  
refractory anemia with excess blasts  
refractory anemia with excess blasts in transformation  
secondary acute myeloid leukemia
de novo myelodysplastic syndromes
secondary myelodysplastic syndromes
childhood myelodysplastic syndromes

Study placed in the following topic categories:
Daunorubicin
Hydrocortisone
Precancerous Conditions
Refractory anemia
Amsacrine
Leukemia, Myeloid, Acute
Etoposide phosphate
Leukemia
Preleukemia
Anemia, Refractory
Leukemia, Promyelocytic, Acute
Neoplasm Metastasis
Methotrexate
Etoposide
Acute myelocytic leukemia
Cytarabine
Myelodysplastic syndromes
Asparaginase
Cortisol succinate
Hematologic Diseases
Myelodysplastic Syndromes
Myelodysplasia
Myeloproliferative Disorders
Anemia
Acute myelogenous leukemia
Acute promyelocytic leukemia
Leukemia, Myeloid
Folic Acid
Mitoxantrone
Anemia, Refractory, with Excess of Blasts

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Antibiotics, Antineoplastic
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Syndrome
Abortifacient Agents
Analgesics
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Disease
Neoplasms by Histologic Type
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2008




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