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Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov 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)

November 1, 1999
January 27, 2003
September 20, 2013
March 1998
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Complete list of historical versions of study NCT00003602 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
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

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.


  • 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.

Phase 3
Allocation: Randomized
Primary Purpose: Treatment
  • Leukemia
  • Myelodysplastic Syndromes
  • Drug: cytarabine
  • Drug: etoposide
  • Drug: idarubicin
  • Drug: mitoxantrone hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
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  • 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
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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Riverside Haematology Group
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Study Chair: Graham Jackson, MD Newcastle-upon-Tyne Hospitals NHS Trust
National Cancer Institute (NCI)
January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP