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NCT Number: NCT07483385

Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell Transplantation

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.

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Key information

Conditions

Patients With Hematologic Disorders After Allogeneic Hematopoietic Stem Cell Transplantation Hematologic Diseases Hematologic Disorders Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The General Hospital of the People's Liberation Army

Chengdu, China

Location status: Recruiting

Location contact

Lei Ma

CONTACT

[email protected]

+8615680600612

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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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Treatment and study plan

Lusutrombopag

Drug

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 outcomes

  1. Transplantation + 21-day platelet accumulation engraftment rate Description: Transplantation + 21-day platelet accumulation engraftment rate

    Time frame: 21 days

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Ma

CONTACT

[email protected]

+8615680600612

Sponsors and collaborators

Lead sponsor

The General Hospital of Western Theater Command

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 19, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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