NCT07894861Not yet recruitingPhase 3
Efficacy and Safety of Maximum Labeled Dose Luspatercept in Lower-Risk Myelodysplastic Syndromes
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 19 Oct 2026
- Start date
- 31 Oct 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT07894861
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 75
- From 31 Oct 2026 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with disease-modifying agents for 4 weeks, or at least one cycle of hypomethylating agents;
- Previously received organ or stem cell transplantation;
- 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;
- Received attenuated vaccine 4 in weeks before enrollment;
- Participation in another clinical trial within 4 weeks before the start of this trial;
- Previously treated with luspatercept. Pregnant or breast-feeding patients;
Other illness
- 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;
- Patients with HBV, HCV, HIV or other infections that require treatment History of immunodeficiency, or congenital immunodeficiency disorders;
- Having a history of mental illness or suffering from severe cerebrovascular diseases or cognitive sequelae, etc;
- Have an allergy to luspatercept or any other part of this medicine;
Lab values
- Platelet count \<50 × 10\^9/L;
- 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;
Other
- Diagnosis of secondary MDS;
- Patients considered to be ineligible for the study by the investigator for reasons other than the above.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.