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Investigation of the Modulatory Effects of Romiplostim on Immune Reconstitution Following Allogeneic Hematopoietic Stem Cell Transplantation: Dynamic Assessment via Fine Immune Subset Profiling and Mechanistic Exploration

Investigation of the Modulatory Effects of Romiplostim on Immune Reconstitution Following Allogeneic Hematopoietic Stem Cell Transplantation: Dynamic Assessment via Fine Immune Subset Profiling and Mechanistic Exploration

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126777
Enrollment
Unknown
Registered
2026-06-15
Start date
2026-06-22
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Acute leukemia, myelodysplastic syndromes, and severe aplastic anemia

Interventions

Romiplostim group:None
standard supportive care:None

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age:? 18 to 65 years, inclusive. 2.Patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) for hematologic diseases. 3.Karnofsky Performance Status (KPS) score = 70%. 4.Written informed consent obtained from both the patient and the donor.

Exclusion criteria

Exclusion criteria: 1.Uncontrolled severe infection. 2.Severe hepatic or renal dysfunction, or cardiopulmonary insufficiency. 3.Active thrombosis. 4.Any concomitant medical condition that, in the investigator's judgment, would compromise patient safety or significantly interfere with the patient's ability to complete the study. 5.Known hypersensitivity or contraindication to the investigational product (active ingredient and/or excipients).

Design outcomes

Primary

MeasureTime frame
Peripheral blood Treg cell percentage and absolute count on day 30 post-transplantation.;

Secondary

MeasureTime frame
Incidence of GVHD;Time to Platelet Engraftment;NK cell functional maturity;Infectious events;T cell subset reconstitution;Cytokines and biomarkers;Survival outcomes;

Countries

China

Contacts

Public ContactXinguang Liu

Qilu Hospital of Shandong University

liuxingrant@163.com+86 531 8216 9758

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026