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Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients 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: NCT00002658
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of different treatment regimens in treating patients who have acute myeloid leukemia.


Condition Intervention Phase
Cancer-Related Problem/Condition
Leukemia
 Drug: amsacrine
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: filgrastim
Drug: idarubicin
Drug: mitoxantrone hydrochloride
Drug: thioguanine
Drug: tretinoin
Procedure: allogeneic bone marrow transplantation
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Procedure: radiation therapy
 Phase III

MedlinePlus related topics: Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Cyclophosphamide Filgrastim Cytarabine Cytarabine hydrochloride Etoposide Idarubicin Idarubicin hydrochloride Daunorubicin hydrochloride Daunorubicin Mitoxantrone hydrochloride Mitoxantrone Etoposide phosphate Tretinoin Thioguanine Amsacrine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: ACUTE MYELOID LEUKAEMIA TRIAL 12

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

Estimated Enrollment: 2000
Study Start Date: January 1994
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • De novo or secondary acute myeloid leukemia of any morphologic type

    • Acute promyelocytic leukemia also entered on MRC ATRA trial
    • No blastic transformation of chronic myeloid leukemia

PATIENT CHARACTERISTICS:

Age:

  • 15 to physiologic 59
  • Patients for whom intensive therapy is considered inappropriate may be entered on protocol MRC-LEUK-AML11 or its successor

Performance status:

  • Any status

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No concurrent active malignancy
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior cytotoxic 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: NCT00002658

Locations
United Kingdom, Wales
University of Wales College of Medicine
Cardiff, Wales, United Kingdom, CF14 4XN
Sponsors and Collaborators
Medical Research Council
Investigators
Study Chair: Alan K. Burnett, MD, FRCP The University of New South Wales
  More Information

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

Publications:
Gale RE, Hills R, Kottaridis PD, Srirangan S, Wheatley K, Burnett AK, Linch DC. No evidence that FLT3 status should be considered as an indicator for transplantation in acute myeloid leukemia (AML): an analysis of 1135 patients, excluding acute promyelocytic leukemia, from the UK MRC AML10 and 12 trials. Blood. 2005 Nov 15;106(10):3658-65. Epub 2005 Aug 2.
Peniket A, Wainscoat J, Side L, Daly S, Kusec R, Buck G, Wheatley K, Walker H, Chatters S, Harrison C, Boultwood J, Goldstone A, Burnett A. Del (9q) AML: clinical and cytological characteristics and prognostic implications. Br J Haematol. 2005 Apr;129(2):210-20.
Burnett AK, Milligan D, Hills RK, et al.: Does all-transretinoic acid (ATRA) have a role in non-APL acute myeloid leukaemia? Results from 1666 patients in three MRC trials. [Abstract] Blood 104 (11): A-1794, 2004.
Wheatley K, Clayton D. Be skeptical about unexpected large apparent treatment effects: the case of an MRC AML12 randomization. Control Clin Trials. 2003 Feb;24(1):66-70.
Webb DK, Harrison G, Stevens RF, Gibson BG, Hann IM, Wheatley K; MRC Childhood Leukemia Working Party. Relationships between age at diagnosis, clinical features, and outcome of therapy in children treated in the Medical Research Council AML 10 and 12 trials for acute myeloid leukemia. Blood. 2001 Sep 15;98(6):1714-20.

Study ID Numbers: CDR0000064208, MRC-LEUK-AML12, EU-95001
Study First Received: November 1, 1999
Last Updated: October 18, 2008
ClinicalTrials.gov Identifier: NCT00002658  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated adult acute myeloid leukemia
adult acute erythroid leukemia (M6)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute promyelocytic leukemia (M3)
adult acute myelomonocytic leukemia (M4)
 adult acute monoblastic leukemia (M5a)
adult acute megakaryoblastic leukemia (M7)
secondary acute myeloid leukemia
adult acute monocytic leukemia (M5b)
neutropenia
adult acute minimally differentiated myeloid leukemia (M0)

Study placed in the following topic categories:
Leukemia, Monocytic, Acute
Daunorubicin
Acute myelomonocytic leukemia
Amsacrine
Cyclophosphamide
Leukemia, Myeloid, Acute
Di Guglielmo's syndrome
Etoposide phosphate
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasm Metastasis
Acute erythroblastic leukemia
Acute myeloid leukemia, adult
Acute myelocytic leukemia
 Etoposide
Cytarabine
Thioguanine
Acute promyelocytic leukemia
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myelomonocytic, Acute
Neutropenia
Idarubicin
Leukemia, Erythroblastic, Acute
Tretinoin
Mitoxantrone
Acute monoblastic leukemia

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antiviral Agents
Immunosuppressive Agents
 Pharmacologic Actions
Neoplasms
Sensory System Agents
Therapeutic Uses
Myeloablative Agonists
Peripheral Nervous System Agents
Analgesics
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Central Nervous System Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009



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