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Cytarabine and Daunorubicin With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

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: NCT00121303
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : September 20, 2016
Information provided by (Responsible Party):
Stichting Hemato-Oncologie voor Volwassenen Nederland

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether cytarabine and daunorubicin followed by gemtuzumab ozogamicin is more effective than cytarabine and daunorubicin in treating acute myeloid leukemia or myelodysplastic syndromes.

PURPOSE: This randomized phase III trial is studying cytarabine and two different doses of daunorubicin to see how well they work compared to cytarabine and daunorubicin followed by gemtuzumab ozogamicin in treating older patients with acute myeloid leukemia or myelodysplastic syndromes.

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Drug: cytarabine Drug: daunorubicin hydrochloride Drug: gemtuzumab ozogamicin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Induction and Post Induction Therapy in Older Patients (≥61 Years of Age) With Acute Myeloid Leukemia (AML) and Refractory Anemia With Excess Blasts (RAEB, RAEB-t)
Study Start Date : January 2005
Actual Primary Completion Date : January 2009
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Active Comparator: Arm A low dose Dauno
Induction 45 mg Dauno
Drug: cytarabine
Drug: daunorubicin hydrochloride
Experimental: ARM B high dose Dauno
Induction 90 mg Dauno
Drug: cytarabine
Drug: daunorubicin hydrochloride
No Intervention: Arm 1 no further treatment
Experimental: Arm 2 Mylotarg
Post induction treatment with Mylotarg
Drug: gemtuzumab ozogamicin

Primary Outcome Measures :
  1. Event-free survival after induction therapy
  2. Disease-free survival after maintenance therapy

Secondary Outcome Measures :
  1. Complete remission (CR) rate after induction therapy
  2. Overall survival after induction therapy
  3. Toxicity after induction therapy
  4. Toxicity after maintenance therapy
  5. Probability of relapse and death in first CR after maintenance therapy
  6. Overall survival after maintenance therapy

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:   61 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed diagnosis of 1 of the following:

    • Acute myeloid leukemia (AML)

      • M0-M2 or M4-M7 FAB subtype

        • No AML with cytogenetic abnormality t(15;17) (M3)
      • Patients with secondary AML progressing from prior myelodysplasia* or biphenotypic leukemia are eligible
    • Refractory anemia with excess blasts (RAEB) or RAEB in transformation

      • International Prognostic Scoring System score ≥ 1.5 NOTE: *Any prior hematological disease of ≥ 4 months duration
  • No chronic myelogenous leukemia in blastic crisis
  • No prior polycythemia rubra vera
  • No primary myelofibrosis



  • 61 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • Not specified


  • ALT and/or AST ≤ 2.5 times upper limit of normal (ULN)*
  • Bilirubin ≤ 2 times ULN* NOTE: *Unless elevation is caused by organ infiltration by AML


  • Creatinine ≤ 2 times ULN* NOTE: *Unless elevation is caused by organ infiltration by AML


  • No myocardial infarction within the past 6 months
  • LVEF > 50% by MUGA, echocardiogram, or other methods
  • No unstable angina
  • No unstable cardiac arrhythmia
  • No severe and/or uncontrolled hypertension


  • No uncontrolled diabetes
  • No severe and/or uncontrolled infection
  • No other severe and/or uncontrolled medical condition


Biologic therapy

  • Not specified


  • More than 6 months since prior chemotherapy

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • No prior induction therapy for AML or myelodysplastic syndromes

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): NCT00121303

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United Kingdom
North Hampshire Hospital
Basingstoke, England, United Kingdom, RG24 9NA
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT2 7NR
Medway Maritime Hospital
Gillingham Kent, England, United Kingdom, ME7 5NY
Maidstone Hospital
Maidstone, England, United Kingdom, ME16 9QQ
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom, TR1 3LJ
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Stichting Hemato-Oncologie voor Volwassenen Nederland
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Study Chair: Jonathan Kell, MRCPath University Hospital of Wales

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Responsible Party: Stichting Hemato-Oncologie voor Volwassenen Nederland Identifier: NCT00121303    
Other Study ID Numbers: CDR0000433422
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Keywords provided by Stichting Hemato-Oncologie voor Volwassenen Nederland:
adult acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
refractory anemia with excess blasts in transformation
refractory anemia with excess blasts
secondary acute myeloid leukemia
untreated adult acute myeloid leukemia
de novo myelodysplastic syndromes
adult acute minimally differentiated myeloid leukemia (M0)
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)
secondary myelodysplastic syndromes
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Anemia, Refractory, with Excess of Blasts
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Anemia, Refractory
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors