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

Phase 2

• Conditions: AML in Remission
• Interventions: Drug: ID cytarabine; Drug: Idarubicin

• Registration Number: NCT04216771
• Lead Sponsor: Fujian Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-29
• Status Verified: 2020-01
• Study Start: 2020-01
• Study First Submitted QC: 2020-01-01
• Last Update Submitted: 2020-01-01
• Study First Posted: 2020-01-03
• Last Update Posted: 2020-01-03
• Primary Completion: 2022-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ID Cytarabine	ID cytarabine	-
IDA with ID Cytarabine	ID cytarabine	-
IDA with ID Cytarabine	Idarubicin	-

Primary Outcome Measures

Name	Time	Method
Relapse free survival	2 years	RFS

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 years	OS
Toxicities	enitire study course until 2 years	Number and CTC grade of all adverse events related to study treatment analyzed in an descriptive way
Minimum Residual Disease	6, 9, 12,18 and 24 months	Immunophenotypic characterization of human bone marrow cells will be done to determine MRD

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China