Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002658
First received: November 1, 1999
Last updated: December 18, 2013
Last verified: October 2002
  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
Leukemia
Neutropenia
Biological: filgrastim
Drug: amsacrine
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
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
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: ACUTE MYELOID LEUKAEMIA TRIAL 12

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002658

Locations
United Kingdom
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 University Hospital of Wales
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00002658     History of Changes
Other Study ID Numbers: CDR0000064208, MRC-LEUK-AML12, EU-95001
Study First Received: November 1, 1999
Last Updated: December 18, 2013
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)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neutropenia
Leukemia
Neoplasms by Histologic Type
Neoplasms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Cyclophosphamide
Mitoxantrone
Daunorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014