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
|
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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 |

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 |
- Event-free survival after induction therapy
- Disease-free survival after maintenance therapy
- Complete remission (CR) rate after induction therapy
- Overall survival after induction therapy
- Toxicity after induction therapy
- Toxicity after maintenance therapy
- Probability of relapse and death in first CR after maintenance therapy
- Overall survival after maintenance therapy

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

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
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 |
Study Chair: | Jonathan Kell, MRCPath | University Hospital of Wales |
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 |