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Clinical study for GHA combined with Azacitidine regimen in the treatment of elderly patients with acute myeloid leukemia

Clinical study for GHA combined with Azacitidine regimen in the treatment of elderly patients with acute myeloid leukemia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032256
Enrollment
Unknown
Registered
2020-04-24
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-04-27

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

Conditions

Acute myeloid leukemia

Interventions

Case series:GHA+AZA regimen

Sponsors

The First Affiliated Hospital of Zhejiang University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Primary acute myeloid leukemia patients, and written informed consents were obtained from patients or family members; 2. The newly diagnosed AML patients (except M3) were classified by WHO classification standard, including AML transformed from MDS; 3. Patients over 65 years old or 60-65 years old with complications or poor physical condition; 4. At the time of selection, the ECoG score of patients over 65 years old was 0-2, and that of patients over 60-65 years old was 2-4.

Exclusion criteria

Exclusion criteria: 1. Systemic or local treatment including chemotherapy within three weeks before admission; 2. Patients over 65 years old: liver and kidney function: bilirubin>2mg/dl (35 umol/L), AST/ALT more than twice the upper limit of normal value, creatinine>177µmol/L, creatinine clearance rate<60ml/min; 3. Abnormal cardiac function EF<=50%; 4. Expected survival <3 months; 5. Chronic or current active infectious diseases requiring systemic antibiotics, antifungal drugs or antiviral treatment; 6. Other concurrent and uncontrolled subjects believed to affect the medical status of patients participating in the study. Psychiatric patients or other patients who are known or suspected to be unable to fully comply with the protocol; 7. Patients with HIV.

Design outcomes

Primary

MeasureTime frame
Complete remission rate;Complete remission with incomplete blood recovery rate;Partial remission rate;

Secondary

MeasureTime frame
Overall survial duration;Relapse-free survial duration;

Countries

China

Contacts

Public ContactJie Jin

The First Affiliated Hospital of Zhejiang University Medical College

jiej0503@zju.edu.cn+86 13505716779

Outcome results

None listed

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