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

Randomized Comparison of Consolidation Treatment in Elderly Patients With Acute Myeloid Leukemia: Idarubicin (IDA) Combined With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone

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 Overview

• Status: Recruiting
• Conditions: AML in Remission
• Intervention / Treatment: Drug: Idarubicin; Drug: ID cytarabine

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDA with ID Cytarabine	Drug: Idarubicin; Idarubicin 10mg/m²/day, D1 (IV); Drug: ID cytarabine; Cytarabine 1.5g/m² /12h, D1-D3 (IV)
Active Comparator: ID Cytarabine	Drug: ID cytarabine; Cytarabine 1.5g/m² /12h, D1-D3 (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse free survival	RFS	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: December 29, 2019
• First Submitted That Met QC Criteria: January 1, 2020
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: January 1, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cytarabine; Idarubicin
• Other Study ID Numbers: AML-19-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No