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Optimization of DA/IA regimen in the induction of de-novo acute myeloid leukemia based on peripheral residual blast clearance rate

A single center, prospective clinical study of the optimization of DA/IA regimen in the induction of de-novo acute myeloid leukemia based on peripheral residual blast level

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-15006085
Enrollment
Unknown
Registered
2015-02-07
Start date
2014-12-01
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

Interventions

Study Group:HHT 2mg/m2, ivgtt, d6-d10

Sponsors

Rui Jin hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Institute of Hematology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 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; 5. Liver and renal function: serum bilirubin<=35umol/L, AST/ALT lower than 2* upper normal serum level, creatinine<=150umol/L; 6. Normal cardiac function: NYHA I/II; 7. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2; 8. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. APL, previous MDS history, treatment related AML; 2. Previously treated patients; 3. Allergy to any medication in the regimen; 4. Contraindication to anthracyclines; 5. Liver and renal insufficiency (beyond the inclusion criteria); 6. Heart failure NYHA III/IV, severe arrhythmia and myocardial infarction; 7. Patients with a "currently active" second malignancy; 8. Patients with "currently active" tuberculosis. Patients with HIV; 9. Patients with other hematological disease; 10. Patients with pregnancy or lactation; 11. Patients who can't understand or obey the protocol; 12. Patients with a history of intolerance or allergy to the same kind of medication in the regimen; 13. Patients aged beyond 18~55 years; 14. Patients participated in other clinical trial; 15. Other circumstance that obstructs the clinical trial.

Design outcomes

Primary

MeasureTime frame
Overall Survival;Relapse Free Survival;Complete Remission Rate;

Secondary

MeasureTime frame
Early Death Rate;Toxicity and Safety;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 28, 2026