Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell Transplantation

March 22, 2026 updated by: The General Hospital of Western Theater Command
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chengdu, China
        • Recruiting
        • The General Hospital of the People's Liberation Army
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Drug: Lusutrombopag
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The General Hospital of Western Theater Command

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2026

Primary Completion (Estimated)

January 28, 2027

Study Completion (Estimated)

January 28, 2028

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025ky69-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hematologic Disorders

Clinical Trials on Lusutrombopag

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe