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Status:

COMPLETED

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

Lead Sponsor:

Stichting Hemato-Oncologie voor Volwassenen Nederland

Conditions:

Leukemia

Myelodysplastic Syndromes

Eligibility:

All Genders

61-120 years

Phase:

PHASE3

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. Mo...

Detailed Description

OBJECTIVES: Primary * Compare the event-free and disease-free survival of older patients with acute myeloid leukemia, refractory anemia with excess blasts (RAEB), or RAEB in transformation treated w...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 61 and over
  • Performance status
  • WHO 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Not specified
  • Hepatic
  • 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
  • Renal
  • Creatinine ≤ 2 times ULN\* NOTE: \*Unless elevation is caused by organ infiltration by AML
  • Cardiovascular
  • 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
  • Other
  • No uncontrolled diabetes
  • No severe and/or uncontrolled infection
  • No other severe and/or uncontrolled medical condition
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • More than 6 months since prior chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • Not specified
  • Surgery
  • Not specified
  • Other
  • No prior induction therapy for AML or myelodysplastic syndromes

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 1 2016

    Estimated Enrollment :

    600 Patients enrolled

    Trial Details

    Trial ID

    NCT00121303

    Start Date

    January 1 2005

    End Date

    June 1 2016

    Last Update

    September 20 2016

    Active Locations (6)

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

    Page 1 of 2 (6 locations)

    1

    North Hampshire Hospital

    Basingstoke, England, United Kingdom, RG24 9NA

    2

    Kent and Canterbury Hospital

    Canterbury, England, United Kingdom, CT2 7NR

    3

    Medway Maritime Hospital

    Gillingham Kent, England, United Kingdom, ME7 5NY

    4

    Maidstone Hospital

    Maidstone, England, United Kingdom, ME16 9QQ