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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001475

Enrollment

Unknown

Registered

2011-08-12

Start date

2010-05-01

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

FA:Fludarabine 30mg/ m2, intravenously administration daily for 3 days

Cytarabine 2g/ m2,intravenously administration daily for 3 days, 6 cycles in total

FA:Fludarabine 30mg/ m2, intravenously administration daily for 5 days

Cytarabine 1g/ m2,intravenously administration daily for 5 days, 6 cycles in total

Cytarabine 2g/ m2,intravenously administration daily for 5 days, 4 cycles in total

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 60 years old; 2. patients in low-risk or middle-risk; 3. patients who were initially diagnosed as AML (excluding M3) finished 1 or 2 courses of regular dosage induction chemotherapy and reached CR; 4. Life expectancy >= 3 months; 5. Able and willing to provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who received non-regular induction chemotherapy, or reached NR after induction chemotherapy; 2. Patients in high-risk or with the diagnosis of M3 according WHO standard; 3. Previous diagnosis of other malignant tumor; 4. Evidence of extramedullary infiltration; 5. Serum total bilirubin >2mg/dL(35 mmol/L), or AST/ALT >2.5*upper limit of normal (ULN), or alkaline phosphatase >3.0*ULN; 6. Renal failure with serum creatinine >150umol/L; 7. positive finding on HIV test; 8. ECOG performance status >= 2; 9. Severe active viral hepatitis especially HBV or HCV infection; 10. Other severe diseases ( uncontrolled infection, diabetes or cardiac failur); 11. Pregnant or lactating females; 12. Known irritable the physique; 13. Enrolled in other clinical trials now or within 30 days before; 14. Unsuitable to enter this trial by researchers' judgement.

Design outcomes

Primary

Measure	Time frame
continuous complete remission rate (CCR);	—

Secondary

Measure	Time frame
overall survival (OS);progress free survival (PFS);	—

Countries

China

Contacts

Public ContactDepei Wu

wudepei@medmail.com.cn+86 0512 67781851

Outcome results

None listed

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