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

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ClinicalTrials.gov Identifier: NCT04216771
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Jianda Hu, 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.

Condition or disease Intervention/treatment Phase
AML in Remission Drug: Idarubicin Drug: ID cytarabine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2024


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)




Primary Outcome Measures :
  1. Relapse free survival [ Time Frame: 2 years ]
    RFS


Secondary Outcome Measures :
  1. Toxicities [ Time Frame: enitire study course until 2 years ]
    Number and CTC grade of all adverse events related to study treatment analyzed in an descriptive way

  2. Minimum Residual Disease [ Time Frame: 6, 9, 12,18 and 24 months ]
    Immunophenotypic characterization of human bone marrow cells will be done to determine MRD

  3. Overall survival [ Time Frame: 2 years ]
    OS



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216771


Contacts
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Contact: Jianda Hu, Prof.M.D.Ph.D 86-13959169016 drjiandahu@163.com

Locations
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China, Fujian
Fujian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China, 350001
Contact: Jianda Hu, Prof.    86-13959169016    drjiandahu@163.com   
Contact: Ting Yang, Prof.    86-13950210357    yang.hopeting@gmail.com   
Principal Investigator: Jianda Hu, Prof.         
Sponsors and Collaborators
Fujian Medical University
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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: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cytarabine
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors