Actively Recruiting
Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell Transplantation
Led by The General Hospital of Western Theater Command · Updated on 2026-03-25
45
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness and safety of Lusutrombopag in helping platelet recovery after allogeneic hematopoietic stem cell transplantation in patients with blood disorders. This is a prospective, single-center, open-label clinical trial led by The General Hospital of Western Theater Command. The study focuses on patients undergoing transplantation and aims to assess platelet remodeling and engraftment rates. Participants will receive Lusutrombopag starting at 3 mg once daily. Treatment lasts for up to two weeks until complete response is achieved, discontinued after 14 days of continuous therapy, or if certain stopping criteria are met. After this treatment period plus an additional 14 days, patients will be monitored to determine if ongoing medication or changes in regimen are needed. During the study, researchers will track the platelet accumulation engraftment rate 21 days after transplantation as the primary outcome. Secondary outcomes include measuring the median time to platelet and neutrophil engraftment within 30 days post-transplant. Participants will be regularly assessed for clinical efficacy and safety outcomes throughout and after the treatment period. The total duration includes treatment, observation, and follow-up to ensure comprehensive monitoring of patient responses.
CONDITIONS
Brief Title
Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and voluntary participation
- Undergoing HLA haploidentical allogeneic hematopoietic stem cell transplantation
- Age 18 years or older, any gender
- ECOG performance status of 0 to 2
- Expected survival of 3 months or more
- No severe impairment of major organ function
You will not qualify if you...
- Known allergy to thrombopoietin receptor agonists (TPO-RAs)
- Unable to take oral medication due to gastrointestinal symptoms, altered mental status, or similar during transplantation
- Other exclusion reasons as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 weeks
Participants receive Lusutrombopag at a starting dose of 3 mg once daily. Treatment continues for 2 weeks until complete response is achieved, or treatment is discontinued after 14 days, or when discontinuation criteria are met.
Daily medication intake with monitoring visits during treatment period
Duration - 14 days
After treatment, participants are observed for an additional 14 days to determine if continued medication or regimen changes are necessary.
Visits during observation period to monitor participant status
Trial Site Locations
Total: 1 location
1
The General Hospital of the People's Liberation Army
Chengdu, China
Actively Recruiting
Research Team
L
Lei Ma
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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