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

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

Study Description
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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 Design
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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

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Arms and Interventions
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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


Outcome Measures
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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

Eligibility Criteria
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Ages Eligible for Study:   61 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00121303


Locations
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
Investigators
Study Chair: Jonathan Kell, MRCPath University Hospital of Wales
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Stichting Hemato-Oncologie voor Volwassenen Nederland
ClinicalTrials.gov Identifier: NCT00121303     History of Changes
Other Study ID Numbers: CDR0000433422
SAKK-AML-43
EU-20514
HOVON-AML-43
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:
Syndrome
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Anemia, Refractory
Anemia, Refractory, with Excess of Blasts
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
 Anemia
Cytarabine
Gemtuzumab
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
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