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

Fujian Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: AML in Remission

Treatments: Drug: Idarubicin; Drug: ID cytarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT04216771

AML-19-01

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

IDA with ID Cytarabine

Experimental group

Treatment:

Drug: Idarubicin

Drug: ID cytarabine

ID Cytarabine

Active Comparator group

Treatment:

Drug: ID cytarabine