Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lusutrombopag.
- Who it may be relevant to
- Registry conditions: Patients With Hematologic Disorders After Allogeneic Hematopoietic Stem Cell Transplantation, Hematologic Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- 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.
Primary outcome measures
- Transplantation + 21-day platelet accumulation engraftment rate Description: Transplantation + 21-day platelet accumulation engraftment rate [Time frame: 21 days]
Secondary outcome measures (1)
- Assess the median time to platelet/ neutrophil engraftment Description: Assess the median time to platelet/ neutrophil engraftment [Time frame: within 30 days post-transplantation]
Eligibility criteria
Inclusion criteria
Participants must meet the following criteria:
- The patient signed an informed consent form and voluntarily participated in the study.
- Patients undergoing HLA haploidentical allogeneic hematopoietic stem cell transplantation;
- Age ≥18 years, regardless of gender
- ECOG score 0-2
- Expected survival ≥3 months
- 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.
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- The General Hospital of the People's Liberation Army — Chengdu
Identifiers
NCT: NCT07483385 · 2025ky69-1