Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

Phase 3

Recruiting

• Conditions: AML
• Interventions: Drug: Daunomycin and Cytarabine (DA Regimen); Drug: Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)

• Registration Number: NCT03021330
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Detailed Description

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 at at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/Q12h on day5-7. In the control arm, patients receive DA regimen with standard dose of cytarabine at a dose of 100mg/㎡/d on day 1-7. Patients receive consolidation therapy containing high-dose cytarabine after achieved complete remission. Stem-cell transplantation is permitted for patients with intermediate- or poor-risk disease. 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.

Study Timeline

• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Study Start: 2017-02-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

1. Age of 14 to 55 years old;
2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
3. ECOG score ≤ 2;
4. Patients with eligible laboratory examination including liver,renal and heart function.
5. 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.

Exclusion Criteria

1. Patients who had received induction therapy.
2. Secondary leukemia.
3. Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
4. 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.
5. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
6. With BCR-ABL fusion gene;
7. Pregnant or lactating women;
8. AML with ineligible renal or liver function;
9. AML with active cardiovascular disease;
10. Severe infection disease including uncured tuberculosis pulmonary aspergillosis;
11. AIDS;
12. Patients had central nervous system involvement when they were diagnosed as AML.
13. Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research.
14. Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results.
15. Patients with other factors which were considered unsuitable to participate in the study by the investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA Regimen	Daunomycin and Cytarabine (DA Regimen)	Patients receive standard DA induction regimen including daunomycin and cytarabine.
Intermediate Dose of DA Regimen	Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)	Patients receive DA induction regimen including daunomycin and intermediate dose of cytarabine.

Primary Outcome Measures

Name	Time	Method
Overall Survival Rate (OS)	Within 5 years after randomization	OS is defined as the time from the date of randomization until the date of death from any cause.

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of relapse	Within 5 years after randomization
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
Early Mortality	within 45 days after randomization

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, Tianjin, China