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A multicenter randomized controlled trial for the effect of maintenance dasatanib or sorafenib after allogeneic hematopoietic stem cell transplantation for core- binding factor acute myeloid leukemia

A multicenter randomized controlled trial for the effect of maintenance dasatanib or sorafenib after allogeneic hematopoietic stem cell transplantation for core- binding factor acute myeloid leukemia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018392
Enrollment
Unknown
Registered
2018-09-15
Start date
2018-09-14
Completion date
Unknown
Last updated
2018-09-17

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

Conditions

hematologic malignacy

Interventions

Group 1:oral dasatanib
Group 2:oral sorafenib
Group 3:oral placebo

Sponsors

the First Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 60 Years

Inclusion criteria

Inclusion criteria: 1. The informed consent is signed by the subjects or their legal representatives before the start of clinical research; 2. Male and female patients,and the female patients with negative pregnancy test; 3. aged younger than 60 years old; 4. Patients diagnosed with acute myeloid leukemia with t(8;21)(q22;q22.1)or inv(16)(p13.1q22) or t(16;16)(p13.1;q22) [inv(16)and t(16;16)] who undergo allogeneic hematopoietic stem cell transplantation; 5. ECOG physical status score 0~2 score; 6. No major organ dysfunction.

Exclusion criteria

Exclusion criteria: 1. Patients with severe liver and renal function and heart and lung dysfunction; 2. An uncontrolled or severe infection; 3. 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. 4.ECOG performance status >2; 5. second tumour; 6. severe neurologic and psychiatric disorder interfering with the ability to consent on the trial.

Design outcomes

Primary

MeasureTime frame
overall survival;disease-free survival;cumulative replase rate;nonreplase mortality;the incidence of acute GVHD and chronic GVHD;Adverse Effects Rate;infection rate;

Countries

China

Contacts

Public ContactHuang He

the First Affiliated Hospital of Zhejiang University School of Medicine

hehuangyu@126.com+86 13605714822

Outcome results

None listed

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