Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

NCT03021330 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: IIT2016007（Cytarabine）
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.

Conditions

AML

Outcome Measures

Primary Outcomes (1)

• Overall Survival Rate (OS)

  OS is defined as the time from the date of randomization until the date of death from any cause.

  Within 5 years after randomization

Secondary Outcomes (5)

• Complete Remission Rate

  Within 2 months after randomization

• Event-Free Survival Rate

  Within 5 years after randomization

• Relapse-Free Survival Rate (RFS)

  Within 5 years after randomization

• Cumulative incidence of relapse

  Within 5 years after randomization

• Early Mortality

  within 45 days after randomization

Study Arms (2)

DA Regimen

ACTIVE COMPARATOR

Patients receive standard DA induction regimen including daunomycin and cytarabine.

Drug: Daunomycin and Cytarabine (DA Regimen)

Intermediate Dose of DA Regimen

EXPERIMENTAL

Patients receive DA induction regimen including daunomycin and intermediate dose of cytarabine.

Drug: Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)

Interventions

Daunomycin and Cytarabine (DA Regimen) DRUG

Cytarabine at a dose of 100mg/㎡/d on day 1-7. Daunomycin at a dose of 60mg/㎡/d on day 1-3.

Also known as: Daunomycin and Cytarabine

DA Regimen

Daunomycin and Cytarabine (Intermediate Dose of DA Regimen) DRUG

Cytarabine at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/d on day 5-7. Daunomycin at a dose of 60mg/㎡/d on day 1-3.

Also known as: Daunomycin and Cytarabine

Intermediate Dose of DA Regimen

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age of 14 to 55 years old;
• Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
• ECOG score ≤ 2;
• Patients with eligible laboratory examination including liver,renal and heart function.
• Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.

You may not qualify if:

• Patients who had received induction therapy.
• Secondary leukemia.
• Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
• Patients with other blood diseases(for example, haemophiliacs) are excluded.However, patients with abnormal blood count, but with undiagnosed MDS or MPD patients are included.
• Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
• With BCR-ABL fusion gene;
• Pregnant or lactating women;
• AML with ineligible renal or liver function;
• AML with active cardiovascular disease;
• Severe infection disease including uncured tuberculosis pulmonary aspergillosis;
• AIDS;
• Patients had central nervous system involvement when they were diagnosed as AML.
• Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research.
• Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results.
• Patients with other factors which were considered unsuitable to participate in the study by the investigators.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Interventions

Daunorubicin; Cytarabine

Intervention Hierarchy (Ancestors)

Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jianxiang Wang, Dr

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 13, 2017
• Study Start: February 8, 2017
• Primary Completion: May 15, 2026
• Study Completion (Estimated): October 15, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)