Comparing the Consolidation Regimens of IDA With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone for Elderly AML Patients

  • STATUS
    Recruiting
  • End date
    May 23, 2024
  • participants needed
    320
  • sponsor
    Fujian Medical University
Updated on 23 January 2021

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.

Details
Condition AML in Remission
Treatment Idarubicin, ID cytarabine
Clinical Study IdentifierNCT04216771
SponsorFujian Medical University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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