A Clinical Study Comparing Romiplostim and rhTPO for Platelet Engraftment after Umbilical Cord Blood Transplantation

A phase II, randomised, open-label trial of romiplostim versus recombinant human thrombopoietin for platelet engraftment after umbilical cord blood transplantation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500115443

Enrollment

Unknown

Registered

2025-12-26

Start date

2025-12-30

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

Delayed platelet engraftment after umbilical cord blood transplantation

Interventions

Romiplostim Group:Romiplostim for Injectio

The rhTPO Group:Recombinant Human Thrombopoietin for Injection

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-65 years old. 2. Gender: no limit. 3.Patients with hematological malignancies (hematological malignancies) diagnosed by MICM according to the criteria of CSCO Guidelines for the diagnosis and treatment of Hematological Malignancies (2022 Edition), who have indications for UCB hematopoietic stem cell transplantation, without major organ dysfunction, and without transplantation contraindications. 4. Recipient was negative for human leukocyte antigen (HLA) antibody. 5. ECOG score 0-2 or hematopoietic stem cell comorbidity index (HCT-CI) score 0-3. 6. The subjects or their legal representatives fully understand the purpose, protocol and possible risks of the study, agree and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Undergone major (grade 2 or above) surgery within the previous 4 weeks. 2.Congenital or hereditary bone marrow failure diseases. 3.History of stroke or intracranial hemorrhage within the preceding 6 months. 4.Clinically significant cardiovascular disease: uncontrolled or symptomatic arrhythmia, congestive heart failure, myocardial infarction within 6 months before screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease according to the New York Heart Association (NYHA) functional classification. 5. Presence of infectious diseases: such as active human immunodeficiency virus (HIV), or active hepatitis C virus (HCV; RNA polymerase chain reaction PCR positive), or active hepatitis B virus (HBV; DNA PCR positive) infection. 6.Active bacterial or fungal infection. 7.Dependency on illicit drugs or substance abuse. 8.Psychiatric disorders or cognitive impairment. 9.Concurrent participation in another clinical trial. 10.Investigators' judgment of unsuitability for enrollment (e.g., anticipated inability to adhere to treatment due to financial concerns or other issues). 11.Pre-existing diagnosis of myelofibrosis prior to transplantation. 12.Lack of a suitable matched umbilical cord blood unit.

Design outcomes

Primary

Measure	Time frame
Time to Platelet Engraftment;	—

Secondary

Measure	Time frame
Disease-Free Survival / Overall Survival Rate;Cumulative Incidence of Grade II-IV Acute GVHD;Cumulative Incidence of Chronic GVHD;Incidence of Adverse Events;Correlation between TPO Levels and Efficacy;Platelet/Neutrophil Engraftment Rate at Day 42;Time to Neutrophil Engraftment;	—

Countries

China

Contacts

Public ContactZeng Yunxin

The Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen)

zeng_0714@163.com+86 755 81206772

Outcome results

None listed

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