Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

AML Clinical Trial

Official title:

Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03021330
• Other study ID #: IIT2016007-EC-1-1
• Status: Recruiting
• Phase: Phase 3
• Start date: February 8, 2017
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Institute of Hematology & Blood Diseases Hospital, China
• Contact: Lijun Liu
• Phone: 86-22-23909237
• Email: bloodgcp[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• AML

Intervention

Drug:
• Daunomycin and Cytarabine (DA Regimen)
Cytarabine at a dose of 100mg/?/d on day 1-7. Daunomycin at a dose of 60mg/?/d on day 1-3.
• Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)
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.

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complete Remission Rate		Within 2 months after randomization
Secondary	Event-Free Survival Rate		Within 5 years after randomization
Secondary	Relapse-Free Survival Rate (RFS)		Within 5 years after randomization
Secondary	Cumulative incidence of relapse		Within 5 years after randomization
Secondary	Early Mortality		within 45 days after randomization