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An Open-Label Preliminary Study of Romiplostim Versus Recombinant Human Thrombopoietin (rhTPO) in Promoting Platelet Engraftment After Haploidentical Transplantation

An Open-Label Preliminary Study of Romiplostim Versus Recombinant Human Thrombopoietin (rhTPO) in Promoting Platelet Engraftment After Haploidentical Transplantation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121211
Enrollment
Unknown
Registered
2026-03-26
Start date
2026-03-26
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Hematologic tumors

Interventions

Romiplostim Group:All patients received subcutaneous injection of Romiplostim treatment, starting from the 4th day after self HCT, once a week until platelet count reached>50 × 10^9/L, without platele
rhTPO Group:Starting from the 4th day after transplantation, rhTPO (recombinant human thrombopoietin injection) was administered subcutaneously at a daily dose of 15,000 U. Subcutaneous injection was

Sponsors

Xiangya Third Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with hematologic diseases who are evaluated by investigators as suitable for haploidentical hematopoietic stem cell transplantation and meet the following inclusion criteria: 1. Patients receiving haploidentical allogeneic hematopoietic stem cell transplantation, with the conditioning regimen determined by the investigators; 2. Age >=18 years and 60 or Eastern Cooperative Oncology Group (ECOG) score 0–2; expected survival >3 months; 3. Adequate function of major organs: (1) Cardiac function: No history of cardiac disease or coronary heart disease, with cardiac function class I–II; (2) Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 times the upper limit of normal (ULN); (3) Bilirubin <=1.5 times ULN (unless elevation is due to Gilbert’s syndrome or non-hepatic causes); (4) Serum creatinine <=1.5 times ULN; (5) PT/INR <1.5 times ULN and PTT (aPTT) <1.5 times ULN; 4. Absence of other severe diseases that conflict with the study protocol (e.g., autoimmune diseases, immunodeficiency); 5. The patient voluntarily agrees to participate in this clinical research and signs the Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. Patients with other concomitant malignancies requiring treatment; 2. Women who are pregnant or breastfeeding; 3. Patients unable to comply with scheduled follow-up; 4. Patients who cannot guarantee completion of the required treatment plan and follow-up observations; 5. Patients considered by the investigators to be unsuitable for the clinical trial for other reasons.

Design outcomes

Primary

MeasureTime frame
Cumulative incidence of platelet engraftment on day 60 post-transplant;

Secondary

MeasureTime frame
Platelet implantation time;Number of platelet transfusions;Overall survival(OS);Non-relapse mortality (NRM);Relapse;Post-transplant minimal residual disease (MRD) turning positive;Incidence of acute and chronic GVHD;Post-transplant infection incidence;

Countries

China

Contacts

Public ContactXin Li/ Qian Cheng

Department of Hematology, The Third Xiangya Hospital, Central South University, Changsha, People’s Republic of China

lixiner1975@163.com+86 88618814

Outcome results

None listed

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