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

This study is ongoing, but not recruiting participants.

First Received: November 1, 1999 Last Updated: February 6, 2009 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer Leukemia, Childhood

Drug Information available for: Hydrocortisone acetate Hydrocortisone Methotrexate Cytarabine hydrochloride Daunorubicin Daunorubicin hydrochloride Etoposide Amsacrine Mitoxantrone Mitoxantrone hydrochloride Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Etoposide phosphate Hydrocortisone 21-sodium succinate Cytarabine Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate L-Asparaginase

U.S. FDA Resources

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

Estimated Enrollment:	2000
Study Start Date:	July 1998

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 NHS Foundation Trust

More Information

Additional 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
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003436 History of Changes
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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Hydrocortisone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Amsacrine
Preleukemia
Pathologic Processes
Therapeutic Uses
Abortifacient Agents
Methotrexate
Etoposide
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

Asparaginase
Hematologic Diseases
Leukemia, Myeloid
Abortifacient Agents, Nonsteroidal
Neoplasms
Hydrocortisone acetate
Mitoxantrone
Antineoplastic Agents, Phytogenic
Antimetabolites
Daunorubicin
Precancerous Conditions
Immunologic Factors
Antineoplastic Agents
Reproductive Control Agents
Leukemia, Myeloid, Acute

ClinicalTrials.gov processed this record on November 05, 2009