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Intensive Compared With Nonintensive Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

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: NCT00005823
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 18, 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. It is not yet known if stronger doses of chemotherapy given over a longer period of time are as well tolerated or as effective as less intensive chemotherapy.

PURPOSE: This randomized phase III trial is studying intensive regimens of chemotherapy to see how well they work compared to nonintensive regimens of chemotherapy in treating older patients with acute myeloid leukemia or myelodysplastic syndrome.

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: hydroxyurea Drug: idarubicin Drug: mitoxantrone hydrochloride Drug: thioguanine Drug: tretinoin Drug: valspodar Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Trial for Patients With Acute Myeloid Leukemia or High Risk Myelodysplatic Syndrome Aged 60 or Over
Study Start Date : December 1998
Actual Study Completion Date : December 2007

Primary Outcome Measures :
  1. Survival
  2. Response achievement
  3. Response duration

Secondary Outcome Measures :
  1. Toxicity by WHO Toxicity Grading after each treatment course
  2. Quality of life EORTC QLQ-C30 at 3 days, 1 month, 3 months, and 6 months from study entry
  3. Resource use (use of blood products, antibiotics and days in hospital) after each treatment course

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Acute myeloid leukemia (de novo or secondary) OR
  • Myelodysplastic syndrome

    • More than 10% myeloblasts in the bone marrow
    • Refractory anemia with excess blasts
    • Refractory anemia with excess blasts in transformation
    • Chronic myelomonocytic leukemia
  • No acute promyelocytic leukemia (FAB type M3)
  • No blastic phase chronic myeloid leukemia



  • 60 and over (younger patients allowed if intensive chemotherapy not indicated)

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • No liver function test ≥ 2 times normal (for non-intensive therapy arm)


  • Not specified


  • No myocardial infarction within past 6 months in patients receiving daunorubicin or PSC 833


  • No other concurrent active malignancy


Biologic therapy:

  • Not specified


  • No prior cytotoxic chemotherapy for leukemia

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified

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): NCT00005823

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United Kingdom
Queen Elizabeth Hospital at University of Birmingham
Birmingham, England, United Kingdom, B15 2RR
University College Hospital
London, England, United Kingdom, WC1E 6AU
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XN
Sponsors and Collaborators
Leukemia Research Fund
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Study Chair: Alan K. Burnett, MD, FRCP University Hospital of Wales
Publications of Results:
Burnett AK, Milligan DW, Prentice AG, et al.: Modification or dose or treatment duration has no impact on outcome of AML in older patients: preliminary results of the UK NCRI AML14 trial. [Abstract] Blood 106 (11): A-543, 2005.
Burnett AK, Milligan D, Prentice AG, et al.: Low dose Ara-C versus hydroxyurea with or without retinoid in older patients not considered fit for intensive chemotherapy: the UK NCRI AML14 trial. [Abstract] Blood 104 (11): A-872, 2004.
Pallis M, Truran L, Grundy M, et al.: P-Glycoprotein overexpresion and internal tandem duplications of FLT3 are characteristic of discrete populations of elderly AML patients. [Abstract] Blood 104 (11): A-196, 2004.

Other Publications:
Layout table for additonal information Identifier: NCT00005823    
Other Study ID Numbers: CDR0000067831
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: September 2006
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 myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute megakaryoblastic leukemia (M7)
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
secondary acute myeloid leukemia
de novo myelodysplastic syndromes
adult acute monocytic leukemia (M5b)
secondary myelodysplastic syndromes
adult acute minimally differentiated myeloid leukemia (M0)
atypical chronic myeloid leukemia, BCR-ABL1 negative
myelodysplastic/myeloproliferative neoplasm, unclassifiable
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
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