Patients With Hematologic Disorders After Allogeneic Hematopoietic Stem Cell TransplantationNCT07483385
Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell Transplantation
A study testing Lusutrombopag in people with Patients With Hematologic Disorders After Allogeneic Hematopoietic Stem Cell Transplantation and Hematologic Disorders, run by The General Hospital of Western Theater Command at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Hematologic Disorders After Allogeneic Hematopoietic Stem Cell Transplantation, Hematologic Disorders
- What is being tested?
- Lusutrombopag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2026to 28 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The General Hospital of the People's Liberation Army
Chengdu
Lei Ma, +8615680600612, 408955783@qq.com
About this study
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
- Patients With Hematologic Disorders After Allogeneic Hematopoietic Stem Cell Transplantation, Hematologic Disorders
- Being tested
- Lusutrombopag
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LusutrombopagDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Drug: Lusutrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplantation + 21-day platelet accumulation engraftment rate Description: Transplantation + 21-day platelet accumulation engraftment rate
Measured: 21 days
Secondary outcomes (1)
Assess the median time to platelet/ neutrophil engraftment Description: Assess the median time to platelet/ neutrophil engraftment
Measured: within 30 days post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start13 Jan 2026
- Primary completion28 Jan 2027 (estimated)
- Study completion28 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Hematologic Disorders After Allogeneic Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The General Hospital of Western Theater Command
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483385
- Sponsor's protocol ID
- 2025ky69-1
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07483385
- Acronym / sponsor ID
- 2025ky69-1
- Conditions
- Patients With Hematologic Disorders After Allogeneic Hematopoietic Stem Cell Transplantation, Hematologic Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The General Hospital of Western Theater CommandUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 28 Jan 2027 (estimated)
- Study completion
- 28 Jan 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Lusutrombopag |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LusutrombopagLusutrombopag 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. | Drug | Treatment Arm |
Primary outcome
Transplantation + 21-day platelet accumulation engraftment rate Description: Transplantation + 21-day platelet accumulation engraftment rate
Time frame: 21 days
1 secondary outcome
Assess the median time to platelet/ neutrophil engraftment Description: Assess the median time to platelet/ neutrophil engraftment
Time frame: within 30 days post-transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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An Exploratory Study on the Use of Gecacitinib in Patients With Myeloid Malignancies and Myelofibrosis During the Peri-transplant Period Following Allogeneic Hematopoietic Stem Cell Transplantation
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A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lusutrombopag in people with Patients With Hematologic Disorders After Allogeneic Hematopoietic Stem Cell Transplantation and Hematologic Disorders, run by The General Hospital of Western Theater Command at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Ma (+8615680600612, 408955783@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplantation + 21-day platelet accumulation engraftment rate Description: Transplantation + 21-day platelet accumulation engraftment rate (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.