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Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003602
Recruitment Status : Unknown
Verified January 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating older patients with acute myeloid leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating older patients with acute myeloid leukemia in first remission.

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Drug: cytarabine Drug: etoposide Drug: idarubicin Drug: mitoxantrone hydrochloride Phase 3

Detailed Description:


  • Compare the efficacy of oral idarubicin and etoposide vs intravenous mitoxantrone, etoposide, and cytarabine as consolidation therapy in patients over 55 years old with acute myeloid leukemia in first complete remission.
  • Compare the toxicity of these 2 regimens in these patients.
  • Assess the quality of life of these patients.

OUTLINE: This is a randomized study. Patients are stratified according to number of courses of induction therapy required to achieve complete remission.

All patients receive induction chemotherapy consisting of idarubicin IV on days 1-3 and cytarabine IV over 12 hours on days 1-7. Patients receive 1-2 courses of induction chemotherapy to achieve complete remission.

Patients are randomized to one of two treatment arms for consolidation therapy after achieving complete remission.

  • Arm I: Patients receive 2 courses of mitoxantrone IV on days 1 and 2, etoposide IV over 1 hour on days 1-5, and cytarabine IV over 12 hours on days 1-5.
  • Arm II: Patients receive 2 courses of oral idarubicin and etoposide on days 1-3.

Quality of life is assessed before each course of consolidation chemotherapy and 6-8 weeks after completion of therapy.

Patients are followed until death.

PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomised Study Comparing an Oral Regimen (Idarubicin and Etoposide) With an Intravenous Regimen (MAE) for Consolidation in Patients Over 55 Years With Acute Myeloid Leukaemia in First Complete Remission
Study Start Date : March 1998

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed de novo or secondary acute myeloid leukemia (AML)

    • Prior myelodysplasia allowed
    • Refractory anemia with excess blasts (RAEB) OR
    • RAEB in transformation
  • No relapsed AML
  • No chronic granulocytic leukemia in transformation
  • No CNS disease



  • Over 55

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Transaminases no greater than 2.5 times ULN


  • Creatinine no greater than 2.5 times ULN


  • No severe or uncontrolled cardiac failure


  • No serious medical, social, or psychological condition
  • Not HIV 1 or 2 seropositive


Biologic therapy:

  • No plan for future autograft


  • No prior chemotherapy for myelodysplastic syndrome or AML

Endocrine therapy:

  • Not specifed


  • Not specified


  • Not specified


  • No concurrent aluminum or magnesium-based antacids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003602

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United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
Sponsors and Collaborators
Riverside Haematology Group
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Study Chair: Graham Jackson, MD Newcastle-upon-Tyne Hospitals NHS Trust
Layout table for additonal information Identifier: NCT00003602    
Other Study ID Numbers: CDR0000066675
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: January 2001
Keywords provided by National Cancer Institute (NCI):
untreated adult acute myeloid leukemia
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
secondary acute myeloid leukemia
de novo myelodysplastic syndromes
secondary myelodysplastic syndromes
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs