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IA regimen as the induction chemotherapy in treatment of acute myeloid leukemia (AML): a multi-center, randomised clinical trial

IA regimen as the induction chemotherapy in treatment of acute myeloid leukemia (AML): a multi-center, randomised clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001479
Enrollment
Unknown
Registered
2011-08-22
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

Group A:Idarubicin 8mg/ m2, intravenously administration daily for 3 days
Cytarabine 100mg/ m2,intravenously administration (mentain 24 hours)
Group B:Idarubicin 10mg/ m2, intravenously administration daily for 3 days

Sponsors

the First Affiliated Hospital of Soochow University
Lead Sponsor

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); 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 meanwhile; 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 reaerch 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

MeasureTime frame
complete remission;

Secondary

MeasureTime frame
desease free suvival;2-year ovrall survival;relapse free 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