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

NCT00003436 | Completed Phase 3

• 3 other identifiers: CDR0000066463MRC-LEUK-AML12CHEU-98010
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia; Myelodysplastic Syndromes

Keywords

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

Interventions

amsacrine DRUG

asparaginase DRUG

cytarabine DRUG

daunorubicin hydrochloride DRUG

etoposide DRUG

methotrexate DRUG

mitoxantrone hydrochloride DRUG

therapeutic hydrocortisone DRUG

allogeneic bone marrow transplantation PROCEDURE

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

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)

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Related Publications (2)

• 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. doi: 10.1038/sj.leu.2403924.

  PMID: 16304572 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Anemia, Refractory, with Excess of Blasts

Interventions

Amsacrine; Asparaginase; Cytarabine; Daunorubicin; Etoposide; Methotrexate; Mitoxantrone; Hydrocortisone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Anemia, Refractory; Anemia

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Anthraquinones; Anthrones; Anthracenes; Quinones; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F

  The Christie NHS Foundation 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: April 30, 2003
• Study Start: July 1, 1998
• Study Completion: December 1, 2005
• Last Updated: December 4, 2013

Record last verified: 2000-12

Locations

GB (1)