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Status:

COMPLETED

Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Conditions:

Leukemia

Myelodysplastic Syndromes

Eligibility:

All Genders

16-70 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as gemtuzum...

Detailed Description

OBJECTIVES: Primary * Determine the feasibility of combining gemtuzumab ozogamicin with idarubicin and cytarabine with or without cyclophosphamide with total body irradiation vs busulfan followed by...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed diagnosis of 1 of the following:
  • High-risk myelodysplastic syndromes (MDS), including any of the following:
  • Refractory anemia with excess blasts (RAEB) with \> 10% blast cells in the bone marrow
  • RAEB in transformation
  • Other forms of MDS with multiple (3 or more) chromosomal abnormalities or chromosome 7 abnormalities AND/OR profound cytopenias, defined as neutrophil count \< 500/mm\^3 and/or platelet count \< 20,000/mm\^3
  • Chronic myelomonocytic leukemia with \> 5% blast cells in the bone marrow
  • Chronic myelomonocytic leukemia with neutrophil count \> 16,000/mm\^3 OR monocyte count \> 2,600/mm\^3
  • Secondary acute myeloid leukemia supervening after overt MDS of more than 6 months in duration
  • Patients with or without an HLA-identical sibling
  • No active CNS leukemia
  • PATIENT CHARACTERISTICS:
  • Age
  • 16 to 70
  • Performance status
  • WHO 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • See Disease Characteristics
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Cardiovascular
  • No severe cardiovascular disease
  • No arrhythmias requiring chronic treatment
  • No congestive heart failure
  • No symptomatic ischemic heart disease
  • Pulmonary
  • No severe lung disease
  • Other
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No HIV positivity
  • No other concurrent malignant disease
  • No active uncontrolled infection
  • No history of alcohol abuse (i.e., averaged less than 5 alcoholic consumptions daily for the past year)
  • No concurrent severe neurological or psychiatric disease
  • No other psychological, familial, sociological, or geographical condition that would preclude study compliance
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 6 weeks since prior growth factors
  • Chemotherapy
  • No prior intensive chemotherapy
  • More than 6 weeks since prior low-dose chemotherapy or hydroxyurea
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • Not specified
  • Surgery
  • Not specified
  • Other
  • More than 6 weeks since prior immunosuppressants
  • No prior participation in this clinical study

Exclusion

    Key Trial Info

    Start Date :

    November 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    31 Patients enrolled

    Trial Details

    Trial ID

    NCT00077116

    Start Date

    November 1 2003

    Last Update

    July 16 2012

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    AZ Sint-Jan

    Bruges, Belgium, 8000

    2

    Institut Jules Bordet

    Brussels, Belgium, 1000

    3

    Cliniques Universitaires Saint-Luc

    Brussels, Belgium, 1200

    4

    H. Hartziekenhuis - Roeselaere.

    Roeselare, Belgium, 8800