NCT04216771UnknownPhase 2
Randomized Comparison of Consolidation Treatment in Elderly Patients With Acute Myeloid Leukemia: Idarubicin (IDA) Combined With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone
Fujian Medical University1 site in 1 country320 target enrollmentStarted: January 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Relapse free survival
Study Overview
Brief Summary
This study evaluates Idarubicin (IDA) in combination with the intermediate-dose cytarabine, compared with intermediate-dose cytarabine alone, as a consolidation treatment for elderly AML in first remission.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Newly diagnosed de novo AML who achieved complete remission (CR), including CRi and CRp after a maximum number of 2 cycles of induction chemotherapy.
- •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
- •Relapsed or refractory AML
- •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
Arms & Interventions
IDA with ID Cytarabine
Experimental
Intervention: Idarubicin (Drug)
IDA with ID Cytarabine
Experimental
Intervention: ID cytarabine (Drug)
ID Cytarabine
Active Comparator
Intervention: ID cytarabine (Drug)
Outcomes
Primary Outcomes
Relapse free survival
Time Frame: 2 years
RFS
Secondary Outcomes
- Overall survival(2 years)
- Toxicities(enitire study course until 2 years)
- Minimum Residual Disease(6, 9, 12,18 and 24 months)
Investigators
Jianda Hu
Director of the department of Hematology
Fujian Medical University
Study Sites (1)
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