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

NCT04216771 | Unknown Phase 2

• 1 other identifier: AML-19-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

AML in Remission

Outcome Measures

Primary Outcomes (1)

• Relapse free survival

  RFS

  2 years

Secondary Outcomes (3)

• Toxicities

  enitire study course until 2 years

• Minimum Residual Disease

  6, 9, 12,18 and 24 months

• Overall survival

  2 years

Study Arms (2)

IDA with ID Cytarabine

EXPERIMENTAL

Drug: Idarubicin; Drug: ID cytarabine

ID Cytarabine

ACTIVE COMPARATOR

Drug: ID cytarabine

Interventions

Idarubicin DRUG

Idarubicin 10mg/m²/day, D1 (IV)

IDA with ID Cytarabine

ID cytarabine DRUG

Cytarabine 1.5g/m² /12h, D1-D3 (IV)

ID Cytarabine; IDA with ID Cytarabine

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Interventions

Idarubicin

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Jianda Hu, Prof.M.D.Ph.D

CONTACT

86-13959169016; drjiandahu@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of Hematology

Study Record Dates

• First Submitted: December 29, 2019
• First Posted: January 3, 2020
• Study Start: January 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2024
• Last Updated: January 3, 2020

Record last verified: 2020-01

Locations

CN (1)