Myelodysplastic SyndromesPhase 3NCT07894861
Efficacy and Safety of Maximum Labeled Dose Luspatercept in Lower-Risk Myelodysplastic Syndromes
A Phase 3 study testing Luspatercept in people with Myelodysplastic Syndromes, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This study is a single-arm, prospective, multi-center, Phase IIIb clinical trial aimed at evaluating the efficacy and safety of the maximum labeled dose of luspatercept in individuals diagnosed with lower-risk myelodysplastic syndromes (MDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- 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
- 75 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 Dec 2027
- Phase
- Phase 3
- 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
- Age ≥18 years;
- Diagnosed with myelodysplastic syndrome with an IPSS-R score ≤3.5;
- Requires at least 2 units of red blood cell transfusions within the 8 weeks prior to treatment;
- ECOG performance status ≤2;
- Willing and able to comply with the requirements for this study and written informed consent.
Who cannot join
- Platelet count <50 × 10^9/L;
- Diagnosis of secondary MDS;
- Previous treatment with disease-modifying agents for 4 weeks, or at least one cycle of hypomethylating agents;
- History of malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors;
- Previously received organ or stem cell transplantation;
- Patients with HBV, HCV, HIV or other infections that require treatment History of immunodeficiency, or congenital immunodeficiency disorders;
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- Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, and other metabolic disorders prior to enrollment;
- Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal values;
- Renal impairment: creatinine clearance <60ml/min;
- Having a history of mental illness or suffering from severe cerebrovascular diseases or cognitive sequelae, etc;
- Received attenuated vaccine 4 in weeks before enrollment;
- Participation in another clinical trial within 4 weeks before the start of this trial;
- Have an allergy to luspatercept or any other part of this medicine;
- Previously treated with luspatercept. Pregnant or breast-feeding patients;
- Patients considered to be ineligible for the study by the investigator for reasons other than the above.
About this study
This study is a single-arm, prospective, multi-center, Phase IIIb clinical trial aimed at evaluating the efficacy and safety of the maximum labeled dose of luspatercept in individuals diagnosed with lower-risk myelodysplastic syndromes (MDS). The trial anticipates the enrollment of 75 participants with lower-risk MDS, all of whom will undergo treatment with luspatercept.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Luspatercept
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuspaterceptDrug
The patients will undergo a maximum 4-week screening period and then enter the treatment phase, where they will receive subcutaneous injections of luspatercept at 1.75 mg/kg every 3 weeks. If adverse events occur during the treatment, the dosage will be reduced or administration postponed depending on their severity.
| Study group | Role | What they receive |
|---|---|---|
| Assigned Interventions | Experimental | Not described Receives: Drug: Luspatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving red blood cell transfusion independence (RBC-TI) for at least 8 weeks
RBC-TI is evaluated by hemoglobin levels and transfusion status
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Liwei, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894861
- Sponsor's protocol ID
- IIT2026030
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Maximum Labeled Dose Luspatercept in Lower-Risk Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT07894861
- Acronym / sponsor ID
- IIT2026030
- Conditions
- Myelodysplastic Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Oct 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 a single-arm, prospective, multi-center, Phase IIIb clinical trial aimed at evaluating the efficacy and safety of the maximum labeled dose of luspatercept in individuals diagnosed with lower-risk myelodysplastic syndromes (MDS). The trial anticipates the enrollment of 75 participants with lower-risk MDS, all of whom will undergo treatment with luspatercept.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions | Experimental | Drug: Luspatercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years;
- Diagnosed with myelodysplastic syndrome with an IPSS-R score ≤3.5;
- Requires at least 2 units of red blood cell transfusions within the 8 weeks prior to treatment;
- ECOG performance status ≤2;
- Willing and able to comply with the requirements for this study and written informed consent.
Key exclusion criteria (15 listed)
- Platelet count <50 × 10^9/L;
- Diagnosis of secondary MDS;
- Previous treatment with disease-modifying agents for 4 weeks, or at least one cycle of hypomethylating agents;
- History of malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors;
- Previously received organ or stem cell transplantation;
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 |
|---|---|---|
| LuspaterceptThe patients will undergo a maximum 4-week screening period and then enter the treatment phase, where they will receive subcutaneous injections of luspatercept at 1.75 mg/kg every 3 weeks. If adverse events occur during the treatment, the dosage will be reduced or administration postponed depending on their severity. | Drug | Assigned Interventions |
Primary outcome
Proportion of patients achieving red blood cell transfusion independence (RBC-TI) for at least 8 weeks
Time frame: 24 weeks
RBC-TI is evaluated by hemoglobin levels and transfusion status
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 26 Oct 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 3 study testing Luspatercept in people with Myelodysplastic Syndromes, 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 5 inclusion and 15 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 26 Oct 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of patients achieving red blood cell transfusion independence (RBC-TI) for at least 8 weeks (time frame: 24 weeks). 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 26 Oct 2026.