NCT07539779Not yet recruitingPhase 2/3
Luspatercept in Preventing Poor Erythroid Engraftment for Hematological Malignancies With Moderate to Severe Myelofibrosis
The Efficacy and Safety of Luspatercept in Preventing Poor Erythroid Engraftment After Allo-HSCT for Hematological Malignancies With Moderate to Severe Myelofibrosis: A Prospective, Multicenter, Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an important treatment for hematological malignancies. Poor erythroid engraftment after transplantation is a serious complication, especially in patients with moderate to severe myelofibrosis (MF). Currently, there is a lack of effective prevention strategies for poor erythroid engraftment after transplantation. Luspatercept, a novel TGF-β superfamily signaling pathway modulator, has shown potential in small-sample studies for the treatment and prevention of post-transplant anemia. Given the high proportion and poor prognosis of poor engraftment function in hematological malignancies with moderate to severe myelofibrosis after transplantation, we plan to conduct a prospective, multicenter, randomized controlled study to explore the efficacy and safety of luspatercept in preventing poor erythroid engraftment after allo-HSCT in hematological malignancies with moderate to severe myelofibrosis.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 196 (estimated)
- First submitted
- 13 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 1 Jan 2030
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT07539779
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 196
- From 1 May 2026 to the primary completion date, 1 Jan 2030
- 1 site in 1 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
- Has previously undergone allo-HSCT;
- Expected lifespan after transplantation is less than 30 days;
Other illness
- Has severe cardiac dysfunction, severe arrhythmia or severe pulmonary dysfunction (obstructive and/or restrictive ventilation disorder);
- Has severe active bleeding;
Lab values
- Has severe liver dysfunction, with liver function indicators (aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL)) more than twice the upper limit of normal;
- Has severe renal dysfunction, with creatinine (Cr) more than twice the upper limit of normal or 24-hour creatinine clearance rate (Ccr) lower than 30 ml/min;
Other
- ECOG score is 3-5;
- Patients judged by the investigator to be unsuitable for participating in this trial.
Who the study is looking for
- Age 18-65 years old, gender not restricted;
- ECOG score 0-2 points;
- Hematological malignancies with moderate to severe myelofibrosis
- Willing to undergo the first allo-HSCT with a suitable donor
- In a CR state before transplantation.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.