Lusutrombopag to help platelet recovery after allogeneic stem cell transplant

Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell Transplantation

This will test whether the oral drug lusutrombopag helps restore platelet counts in adults after HLA haploidentical allogeneic stem cell transplantation for blood disorders.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The General Hospital of Western Theater Command (other)
• Locations: 1 site (Chengdu)
• Trial ID: NCT07483385 on ClinicalTrials.gov

What this trial studies

This is an investigator-initiated, prospective, single-center, open-label trial testing lusutrombopag given after HLA haploidentical allogeneic hematopoietic stem cell transplantation to promote platelet remodeling. Adult patients with hematologic disorders who meet performance and organ-function criteria will receive oral lusutrombopag and undergo regular monitoring of platelet counts and adverse events. The trial will primarily look at platelet recovery dynamics and safety signals such as bleeding, thrombotic events, and other drug-related adverse effects. Findings will inform whether lusutrombopag can shorten time to stable platelet counts and reduce transfusion needs in this transplant population.

Who should consider this trial

Good fit: Adults (≥18 years) undergoing HLA haploidentical allogeneic hematopoietic stem cell transplantation with ECOG 0–2, expected survival of at least three months, no severe major-organ dysfunction, able to take oral medication, and who consent to participate are eligible.

Not a fit: Patients with a known allergy to TPO receptor agonists, those unable to take oral medication, or those with severe organ dysfunction or other contraindications determined by the investigator are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, lusutrombopag could shorten time to platelet recovery, lower bleeding risk, and reduce the need for platelet transfusions after transplant.

How similar studies have performed: Thrombopoietin-receptor agonists including lusutrombopag, eltrombopag, and romiplostim have raised platelet counts in other clinical settings and small studies suggest possible benefit after HSCT, but large randomized data in the post-transplant setting are limited.

Eligibility criteria

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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Where this trial is running

Chengdu

• The General Hospital of the People's Liberation Army — Chengdu, China (RECRUITING)

Study contacts

• Study coordinator: Lei Ma

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