Clinical study of low-dose decitabine with granulocyte stimulating factor combined with Luspatercept to prevent relapse after high-risk acute myeloid leukemia transplantation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400082173

Enrollment

Unknown

Registered

2024-03-22

Start date

2024-04-01

Completion date

Unknown

Last updated

2024-03-25

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:Luspatercept: From 60 days after transplantation, Luspatercept started at 1.0 mg / kg, up-regulated Luspatercept according to the instructions, Q3W, one month before decitabine + G-

After 1 month, G-CSF 5ug / Kgd 0-5, decitabine 10mg * d1-5. Cycle every 2 months, 6 to 8 cycles.

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: A) Patients diagnosed with high-risk acute leukemia and undergoing allogeneic hematopoietic stem cell transplantation, no gender limitation, age 18-60 years; KPS score> 60, estimated survival> 3 months; B) No serious functional impairment of systemic vital organs; c) Voluntary testing, with informed consent.

Exclusion criteria

Exclusion criteria: A) Severe cardiac, renal or hepatic insufficiency; B) Patients with other malignant malignancies that need treatment; C) Clinical symptoms of brain dysfunction or serious mental illness cannot undersand or comply with the study protocol; D) Unable to follow up as scheduled; E) Patients without guaranteed completion of the necessary treatment plans and follow-up observations.

Design outcomes

Primary

Measure	Time frame
Leukemia relapse;	—

Countries

China

Contacts

Public ContactYao Han

Xinqiao Hospital of Army Medical University

marieyaohanhan@outlook.com+86 139 9601 4516

Outcome results

None listed

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