Comparing the Consolidation Regimens of IDA With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone for Elderly AML Patients
NCT ID: NCT04216771
Last Updated: 2020-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
320 participants
INTERVENTIONAL
2020-01-31
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IDA with ID Cytarabine
Idarubicin
Idarubicin 10mg/m²/day, D1 (IV)
ID cytarabine
Cytarabine 1.5g/m² /12h, D1-D3 (IV)
ID Cytarabine
ID cytarabine
Cytarabine 1.5g/m² /12h, D1-D3 (IV)
Interventions
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Idarubicin
Idarubicin 10mg/m²/day, D1 (IV)
ID cytarabine
Cytarabine 1.5g/m² /12h, D1-D3 (IV)
Eligibility Criteria
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Inclusion Criteria
* Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia)
* No contraindication to anthracyclines : decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF (left ventricular ejection fraction) \< 50%
* Age ≥ 60 years and \< 75 years
* ECOG performance status ≤2
* Written informed consent
* No psychological, familial, social, or geographic reason that would compromise clinical follow up
Exclusion Criteria
* Patients with acute promyelocytic leukemia (APL)
* Patients with secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML)
* Severe pshyciatric or organic disorder, supposed to be independent from AML, that would contraindicate treatment
* Subjects for which allogeneic HSCT is planned in CR1
* Known allergic or hypersensitivity to idarubicin or cytarabine or to any of the test compounds, materials
* Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
* A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications
60 Years
75 Years
ALL
No
Sponsors
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Fujian Medical University
OTHER
Responsible Party
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Jianda Hu
Director of the department of Hematology
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AML-19-01
Identifier Type: -
Identifier Source: org_study_id
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