Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell Transplantation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07483385

Enrollment

Registered

2026-03-19

Start date

2026-01-13

Completion date

2028-01-28

Last updated

2026-03-25

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

Conditions

Hematologic Disorders, Patients With Hematologic Disorders After Allogeneic Hematopoietic Stem Cell Transplantation

Brief summary

This study is an investigator-initiated prospective, single-center, open-label clinical trial designed to evaluate the clinical efficacy and safety of Lusutrombopag in promoting platelet remodeling after allogeneic hematopoietic stem cell transplantation in patients with hematologic disorders.

Interventions

DRUGLusutrombopag

Lusutrombopag at a starting dose of 3 mg once daily. Treatment will continue for 2 weeks until CR is achieved, or treatment is discontinued after 14 days of continuous therapy, or when the discontinuation criteria are met. After the trial period plus 14 days, patients will be observed to determine if continued medication or regimen changes are necessary.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Participants must meet the following criteria: 1. The patient signed an informed consent form and voluntarily participated in the study. 2. Patients undergoing HLA haploidentical allogeneic hematopoietic stem cell transplantation; 3. Age ≥18 years, regardless of gender 4. ECOG score 0-2 5. Expected survival ≥3 months 6. No severe impairment of function of major organs

Exclusion criteria

If any of the following criteria are met, the participants must be excluded from this research project: 1\) Patients with known allergy to TPO-RAs; 2) Patients who cannot take oral medication due to gastrointestinal symptoms, altered mental status, etc. during transplantation; 3) Other reasons for exclusion as determined by the investigator. \-

Design outcomes

Primary

Measure	Time frame
Transplantation + 21-day platelet accumulation engraftment rate Description: Transplantation + 21-day platelet accumulation engraftment rate	21 days

Secondary

Measure	Time frame
Assess the median time to platelet/ neutrophil engraftment Description: Assess the median time to platelet/ neutrophil engraftment	within 30 days post-transplantation

Countries

China

Contacts

CONTACTLei Ma

408955783@qq.com+8615680600612

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026