Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell Transplantation

The General Hospital of Western Theater Command of Chinese People's Liberation Army

Status: Enrolling

Conditions: Patients With Hematologic Disorders After Allogeneic Hematopoietic Stem Cell Transplantation; Hematologic Disorders

Treatments: Drug: Lusutrombopag

Study type: Interventional

Funder types: Other

Identifiers

NCT07483385

2025ky69-1

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

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Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Treatment Arm

Experimental group

Treatment:

Drug: Lusutrombopag