Clinical trial · Interventional
Luspatercept vs Epoetin in Treating Poor Erythroid Engraftment for Hematological Malignancies
Luspatercept Versus Epoetin in Treating Poor Erythroid Engraftment for Hematological Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective therapy for hematological malignancies. Nonetheless, poor graft function remains a life-threatening complication after allo-HSCT. Poor erythroid engraftment is associated with increased bleeding events and shorter survival. Current treatment methods such as epoetin or repeated red-cell transfusions are not effective for poor erythroid engraftment, with limited and transient responses. Retrospective studies suggested that luspatercept showed efficacy in patients with anemia post-transplantation or poor erythroid engraftment. However, there are no studies comparing luspatercept versus epoetin for the treatment of poor erythroid engraftment. Therefore, we conducted a randomized controlled study to compared the effect of luspatercept versus epoetin in treating poor erythroid engraftment for hematological malignancies.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epoetin | — | UNRESOLVED | — |
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
| Luspatercept | — | UNRESOLVED | — |
| Poor Erythroid Engraftment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epoetin | Drug | — | UNRESOLVED |
| Luspatercept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Luspatercept group
- description
- Luspatercept
- interventionNames
- Drug: Luspatercept
- type
- ACTIVE_COMPARATOR
- label
- Epoetin group
- description
- Epoetin
- interventionNames
- Drug: Epoetin
Primary outcomes (1)
- measure
- Erythroid response
- timeFrame
- 24 weeks
- description
- Erythroid response is defined as a reduction in transfusion of ≥ 4 red blood cell units/8 weeks or a mean hemoglobin increase of ≥ 1.5 g/dL/8 weeks in the absence of transfusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 18-65 years * Hematologic malignancies * Poor erythroid engraftment after the first allo-HSCT * Complete remission post-transplantation * Eastern Cooperative Oncology Group performance status of 0-2 * Epoetin-naive * Endogenous serum erythropoietin concentration \<500 U/L Exclusion Criteria: * Life expectancy shorter than 30 days post-transplantation * Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)
References
Publications (5)
- BACKGROUNDDella Porta MG, Garcia-Manero G, Santini V, Zeidan AM, Komrokji RS, Shortt J, Valcarcel D, Jonasova A, Dimicoli-Salazar S, Tiong IS, Lin CC, Li J, Zhang J, Pilot R, Kreitz S, Pozharskaya V, Keeperman KL, Rose S, Prebet T, Lai Y, Degulys A, Paolini S, Cluzeau T, Fenaux P, Platzbecker U. Luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): primary analysis of a phase 3, open-label, randomised, controlled trial. Lancet Haematol. 2024 Sep;11(9):e646-e658. doi: 10.1016/S2352-3026(24)00203-5. Epub 2024 Jul 19. PMID 39038479
- BACKGROUNDTang C, Chen F, Kong D, Ma Q, Dai H, Yin J, Li Z, Chen J, Zhu X, Mao X, Wu D, Tang X. Successful treatment of secondary poor graft function post allogeneic hematopoietic stem cell transplantation with eltrombopag. J Hematol Oncol. 2018 Aug 16;11(1):103. doi: 10.1186/s13045-018-0649-6. PMID 30115080
- BACKGROUNDMarkham A. Luspatercept: First Approval. Drugs. 2020 Jan;80(1):85-90. doi: 10.1007/s40265-019-01251-5. PMID 31939073
- BACKGROUNDZhu L, Liu J, Liu H, et al. Clinical Study on the Treatment of Poor Erythroid Engraftment after Allogeneic Hematopoietic Stem Cell Transplantation with Luspatercept. Blood 2024; 144: 2159.
- BACKGROUNDXin X, Zhang W, Li Z, Gui R, Wang J, Ji L, Zhang Y, Fang B, Song Y, Zu Y, Zhou J. Luspatercept for the treatment of anemia in allo-HSCT for patients with hematological diseases. Blood Cancer J. 2025 Feb 5;15(1):12. doi: 10.1038/s41408-025-01218-8. No abstract available. PMID 39910033