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Maintenance therapy with low-dose decitabine and venetoclax after allogeneic stem cell transplantation for patients with acute leukemia/myelodysplastic syndrome: a non-randomised, open-label, phase II study

Maintenance therapy with low-dose decitabine and venetoclax after allogeneic stem cell transplantation for patients with acute leukemia/myelodysplastic syndrome: a non-randomised, open-label, phase II study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025374
Enrollment
Unknown
Registered
2019-08-25
Start date
2019-08-19
Completion date
Unknown
Last updated
2020-10-13

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

Conditions

Acute Myeloid Leukemia

Interventions

experimental group:Decitabine combined with Venetoclax

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, male or female; 2. high risk AML treated by allo-HSCT and 1 month after HSCT; 3. Not relapse after transplantation; 4. ECOG physical status score 0~2 score; 5. Ability to understand and be willing to sign the informed consent form of this trial.

Exclusion criteria

Exclusion criteria: 1. Pregnant women or lactation women; 2. Patients with uncontrolled heart failure, unstable angina, arrhythmia or mental disorders; 3. Uncontrolled infection disease; 4. HIV infected patients; 5. Patients with 3 or high stage chronic renal disease; 6. Relapse of AML; 7. Poor implantation after transplantation or blood routine examination is not satisfied with WBC > 2.0*10^9/L, ANC > 0.5*10^9/L, HBG > 90g/L, PLT > 20*10^9/L; 8. ECOG performance status > 2; 9. Major organ dysfunction.

Design outcomes

Primary

MeasureTime frame
complete remission state of bone marrow;remission state of hematology;event-free survival;overall survival;early mortality rate;

Secondary

MeasureTime frame
T cell subtype;

Countries

China

Contacts

Public ContactMingfeng Zhao

Department of Hematology, Tianjin First Central Hospital

745651529@qq.com+86 18822150507

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026