HSCTPhase 2NCT07450313
The Efficacy and Safety of Luspatercept in Improving Early Anemia After HSCT
A Phase 2 study testing Luspatercept in people with HSCT, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This study aims to evaluate whether luspatercept can improve the efficacy and safety of anemia treatment in patients with hematologic malignancies after allogeneic hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HSCT
- What is being tested?
- Luspatercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2026to 14 Jun 2027
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Diagnosis of malignant hematological tumors and undergoing allogeneic hematopoietic stem cell transplantation.
- 2. Expected survival after transplantation exceeds 1 month.
- 3. Age 18-60 years.
- 4. Hemoglobin ≤60 g/L on day 0 after transplantation.
- 5. Eastern Cooperative Oncology Group (ECOG) score 0-2.
- 6. Able to independently sign the informed consent form.
- 7. The informed consent form must be signed before the start of the study procedures. For individuals aged 18 years and above, the informed consent form should be signed by the patient themselves or their immediate family members. Considering the patient's condition, if signing by the patient themselves is not conducive to treatment, the legal guardian or immediate family member should sign the informed consent form.
Who cannot join
- 1. Uncontrolled infection at the time of enrollment, or requiring mechanical ventilation or hemodynamic instability;
- 2. Severe organic damage: hepatic or renal impairment;
- 3. Occurrence of any of the following within 6 months prior to the study: myocardial infarction, severe/unstable angina pectoris, congestive heart failure, or cerebrovascular accident, including transient ischemic attack;
- 4. Presence of psychiatric disorders or other conditions that may compromise compliance with study treatment and monitoring requirements. Failure to sign the informed consent form;
- 5. Inability or unwillingness to sign the consent form;
- 6. Participation in other transplant-related clinical studies;
- 7. Other circumstances deemed by the investigator as potentially affecting the study or ethics, including drug allergies, patient non-compliance with study procedures, or involvement of the research center staff and their immediate relatives.
About this study
Official title: A Clinical Study on the Efficacy and Safety of Luspatercept in Improving Early Anemia After Allogeneic Hematopoietic Stem Cell Transplantation
This study aims to evaluate whether luspatercept can improve the efficacy and safety of anemia treatment in patients with hematologic malignancies after allogeneic hematopoietic stem cell transplantation.
Read the detailed description
This study aims to investigate whether the early post-transplant application of luspatercept can improve early anemia and transfusion dependency in patients with hematologic malignancies after hematopoietic stem cell transplantation. Meanwhile, the investigators aim to evaluate the safty of administration of luspatercept post-transplantation, and assess its impact on platelet and neutrophil engraftment, as well as its effect on the incidence of complications such as poor graft function.
- Conditions
- HSCT
- Being tested
- Luspatercept
- Keywords
- anemia，HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuspaterceptDrug
Subjects will be screened according to the inclusion and exclusion criteria. Eligible patients enrolled will receive treatment with Luspatercept at a dose of 1.0 mg/kg, administered subcutaneously as a single dose on day +3 after transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Luspatercept treatment | Experimental | Not described Receives: Drug: Luspatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative volume of red blood cell transfusions
Measured: 28 days post-HSCT
Secondary outcomes (10)
Cumulative volume of red blood cell transfusions
Measured: 56 days post-transplantation
Platelet and neutrophil counts
Measured: 2 months post-HSCT
Incidence of poor graft function (PGF).
Measured: one year post-HSCT
Serum/bone marrow GATA1,and GDF11 levels
Measured: 2 months post-HSCT
Levels of inflammatory factors
IL-1, IL-6, IFN-γ, TNF-α.
Measured: 2 months post-HSCT
Incidence of acute graft-versus-host disease (aGVHD).
Measured: one year post-HSCT
Overall Survival
Measured: one year after HSCT
disease-free survival
Measured: one year after HSCT
cumulative incidence of relapse
Measured: one year after HSCT
treatment-related mortality
Measured: one year after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start14 Mar 2026 (estimated)
- Primary completion14 Jun 2027 (estimated)
- Study completion14 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSCTStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450313
- Sponsor's protocol ID
- IIT2025133
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 4 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Efficacy and Safety of Luspatercept in Improving Early Anemia After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07450313
- Acronym / sponsor ID
- IIT2025133
- Conditions
- HSCT
- Keywords
- anemia，HSCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 14 Mar 2026 (estimated)
- Primary completion
- 14 Jun 2027 (estimated)
- Study completion
- 14 Jun 2027 (estimated)
- First posted
- 4 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 aims to evaluate whether luspatercept can improve the efficacy and safety of anemia treatment in patients with hematologic malignancies after allogeneic hematopoietic stem cell transplantation.
Detailed description
This study aims to investigate whether the early post-transplant application of luspatercept can improve early anemia and transfusion dependency in patients with hematologic malignancies after hematopoietic stem cell transplantation. Meanwhile, the investigators aim to evaluate the safty of administration of luspatercept post-transplantation, and assess its impact on platelet and neutrophil engraftment, as well as its effect on the incidence of complications such as poor graft function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luspatercept treatment | Experimental | Drug: Luspatercept |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1. Diagnosis of malignant hematological tumors and undergoing allogeneic hematopoietic stem cell transplantation.
- 2. Expected survival after transplantation exceeds 1 month.
- 3. Age 18-60 years.
- 4. Hemoglobin ≤60 g/L on day 0 after transplantation.
- 5. Eastern Cooperative Oncology Group (ECOG) score 0-2.
Key exclusion criteria (7 listed)
- 1. Uncontrolled infection at the time of enrollment, or requiring mechanical ventilation or hemodynamic instability;
- 2. Severe organic damage: hepatic or renal impairment;
- 3. Occurrence of any of the following within 6 months prior to the study: myocardial infarction, severe/unstable angina pectoris, congestive heart failure, or cerebrovascular accident, including transient ischemic attack;
- 4. Presence of psychiatric disorders or other conditions that may compromise compliance with study treatment and monitoring requirements. Failure to sign the informed consent form;
- 5. Inability or unwillingness to sign the consent form;
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 |
|---|---|---|
| LuspaterceptSubjects will be screened according to the inclusion and exclusion criteria. Eligible patients enrolled will receive treatment with Luspatercept at a dose of 1.0 mg/kg, administered subcutaneously as a single dose on day +3 after transplantation. | Drug | Luspatercept treatment |
Primary outcome
Cumulative volume of red blood cell transfusions
Time frame: 28 days post-HSCT
10 secondary outcomes
Cumulative volume of red blood cell transfusions
Time frame: 56 days post-transplantation
Platelet and neutrophil counts
Time frame: 2 months post-HSCT
Incidence of poor graft function (PGF).
Time frame: one year post-HSCT
Serum/bone marrow GATA1,and GDF11 levels
Time frame: 2 months post-HSCT
Levels of inflammatory factors
Time frame: 2 months post-HSCT
Incidence of acute graft-versus-host disease (aGVHD).
Time frame: one year post-HSCT
Overall Survival
Time frame: one year after HSCT
disease-free survival
Time frame: one year after HSCT
cumulative incidence of relapse
Time frame: one year after HSCT
treatment-related mortality
Time frame: one year after HSCT
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 4 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Luspatercept in people with HSCT, run by Institute of Hematology & Blood Diseases Hospital, 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 7 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: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative volume of red blood cell transfusions (time frame: 28 days post-HSCT). 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 4 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.