A randomised clinical trial to compare the efficacy and safety of IA and intensive DA regimen as induction chemotherapy for de novo acute myeloid leukemia (AML) patients

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001482

Enrollment

Unknown

Registered

2011-08-15

Start date

2011-07-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myeloid leukemia (AML)

Interventions

IA:Idarubicin 12mg/ m2, intravenously administration daily for 3 days

Cytarabine 100mg/ m2,intravenously administration (mentain 24 hours) daily for 7days

intensive DA:Daunorubicin 90mg/ m2, intravenously administration daily for 3 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 60 years old; 2. Able and willing to provide signed informed consent; 3. De novo AML (excluding M3); 4. Normal function of liver and kidney: serum total bilirubin <=35umol/L; AST/ALT < 2.0*upper limit of normal (ULN); serum creatine <=150umol/L; 5. Normal cardiac function; 6. ECOG performance status of 0, 1 or 2 (WHO standard).

Exclusion criteria

Exclusion criteria: 1. Patients who have previous chemotherapy for AML; 2. Hepatic or renal failure; 3. Uncontrolled heart failure; 4. Diagnosis of other malignant tumor; 5. Patients with tuberculosis; 6. Secondary AML; 7. Diagnosis of other hematology diseases; 8. Pregnant or lactating females; 9. Unable to understand or to follow the research protocal; 10. Known hypersensitivity or prior history of uncontrllable side effects to Daunorubicin, Idarubicin,Cytarabine or congener agents; 11. Patients aged below 18 or over 60 years old.

Design outcomes

Primary

Measure	Time frame
complete remission;	—

Secondary

Measure	Time frame
relapse free survival;desease free suvival;2-year ovrall survival;	—

Countries

China

Contacts

Public ContactDepei WU

wudepei@medmail.com.cn+86 512 67781856

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026