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

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Medical University
• Treatments: Cytarabine; Idarubicin

Criteria

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