Optimization of IA regimen in the induction chemotherapy of de-novo acute myeloid leukemia based on peripheral residual disease level

The study of precise standardized chemotherapy in de-novo acute myeloid leukemia patients based on peripheral residual disease level

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIC-16007764

Enrollment

Unknown

Registered

2016-01-14

Start date

2016-01-18

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

Interventions

Standard Induction Group:Standard IA regimen

Control Group:Standard IA regimen

Study Group:Standard IA regimen+HHT 2mg/?, ivgtt, d6-d10

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed AML patients by both morphology and immunology; 2. Rule out APL by morphology and molecular; 3. Rule out MDS history and secondary AML; 4. To be aged 18~55 years [Performance status: Eastern Cooperative Oncology Group (ECOG) 0-3]; 5. To be aged 56~60 years [Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2]; 6. Liver and renal function: serum bilirubin<=35umol/L, AST/ALT lower than 2* upper normal serum level, creatinine<=150umol/L; 7. Normal cardiac function: NYHA I/II; 8. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. APL, previous MDS history, treatment related AML; 2. Previously treated patients; 3. Patients with extramedullary infiltration or central nervous system leukemia 4. Allergy to any medication in the regimen; 5. Contraindication to anthracyclines; 6. Liver and renal insufficiency (beyond the inclusion criteria); 7. Heart failure NYHA III/IV, severe arrhythmia and myocardial infarction; 8. Patients with a "currently active" second malignancy; 9. Patients with "currently active" tuberculosis. Patients with HIV; 10. Patients with other hematological disease; 11. Patients with pregnancy or lactation; 12. Patients who can't understand or obey the protocol; 13. Patients with a history of intolerance or allergy to the same kind of medication in the regimen; 14. Patients aged beyond 18~60 years, and patients aged 56~60 years with ECOG>2; 15. Patients participated in other clinical trial; 16. Other circumstance that obstructs the clinical trial.

Design outcomes

Primary

Measure	Time frame
Complete Remission Rate;Relapse Free Survival;Overall Survival;	—

Secondary

Measure	Time frame
Early Death Rate;Minimal residual disease;	—

Countries

China

Contacts

Public ContactJunmin Li

lijunmin@medmail.com.cn+86 021-64370045-665258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026