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

Sponsor

Fujian Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04216771

Collaborator

(none)

320

Enrollment

Location

Arms

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AML in Remission	Drug: Idarubicin Drug: ID cytarabine	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Relapse free survival [2 years]
RFS

Secondary Outcome Measures

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
Overall survival [2 years]
OS

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fujian Medical University Union Hospital	Fuzhou	Fujian	China	350001

Sponsors and Collaborators

Fujian Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jianda Hu, Director of the department of Hematology, Fujian Medical University

ClinicalTrials.gov Identifier:

NCT04216771

Other Study ID Numbers:

AML-19-01

First Posted:

Jan 3, 2020

Last Update Posted:

Jan 3, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cytarabine

Idarubicin

Study Results

No Results Posted as of Jan 3, 2020