Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell Transplantation

NCT07483385 | Recruiting

• 1 other identifier: 2025ky69-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Transplantation + 21-day platelet accumulation engraftment rate Description: Transplantation + 21-day platelet accumulation engraftment rate

  21 days

Secondary Outcomes (1)

• Assess the median time to platelet/ neutrophil engraftment Description: Assess the median time to platelet/ neutrophil engraftment

  within 30 days post-transplantation

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Drug: Lusutrombopag

Interventions

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.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• If any of the following criteria are met, the participants must be excluded from this research project:

Sponsors & Collaborators

• The General Hospital of Western Theater Command: lead

Study Sites (1)

The General Hospital of the People's Liberation Army

Chengdu, China

RECRUITING

MeSH Terms

Conditions

Hematologic Diseases

Interventions

lusutrombopag

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Central Study Contacts

Lei Ma

CONTACT

+8615680600612; 408955783@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): January 28, 2027
• Study Completion (Estimated): January 28, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)