Efficacy and Safety of Hetrombopag Versus Thrombopoietin in Promoting Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation: A Prospective, Multicenter, Randomized Controlled Clinical Trial

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is pivotal for hematological malignancies but faces challenges in delayed platelet engraftment, poor graft function (PGF), and bleeding risks. Hetrombopag, a thrombopoietin receptor agonist, was evaluated to enhance platelet recovery posttransplant. Patients undergoing allo-HSCT were randomized on Day 3 Post-Infusion into low-dose (2.5 mg/day), high-dose (5 mg/day) hetrombopag groups, or a control group receiving thrombopoietin (300 U/kg/day). Endpoints included platelet/neutrophil engraftment time, PGF incidence, transfusion needs, and safety. Among 212 analyzed patients, platelet engraftment was faster in hetrombopag groups (median 13 days) versus controls (15 days; p = 0.0022), with no dose-dependent difference (p = 0.0593). Neutrophil engraftment was also accelerated (13 vs. 15 days; p = 0.0001). PGF incidence was lower in hetrombopag groups (5.04%) versus controls (13.7%; p = 0.027). The experimental group required fewer platelet transfusions (p = 0.002), had reduced gastrointestinal bleeding, and lower costs. Secondary platelet recovery failure showed no intergroup differences. Hetrombopag safely accelerates platelet and neutrophil engraftment, reduces PGF risk, and decreases transfusion dependency post-allo-HSCT. Low-dose hetrombopag demonstrated efficacy equivalent to high-dose, offering a cost-effective strategy to improve transplant outcomes. Trial Registration: ChiCTR2200057764.

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Publication Details

Journal
American Journal of Hematology
Published
2025-06-19
DOI
https://doi.org/10.1002/ajh.27746
Citations
4
Primary Topic
Platelet Disorders and Treatments
Type
article
Field-Weighted Citation Impact
7.08

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article

Efficacy and Safety of Hetrombopag Versus Thrombopoietin in Promoting Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation: A Prospective, Multicenter, Randomized Controlled Clinical Trial

Hai Yi, Shichun Gao, Pengcheng He, Jianchuan Deng et al.
4 citations
American Journal of Hematology
Platelet Disorders and Treatments
7.08
article

Efficacy and Safety of Hetrombopag Versus Thrombopoietin in Promoting Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation: A Prospective, Multicenter, Randomized Controlled Clinical Trial

Hai Yi, Shichun Gao, Pengcheng He, Jianchuan Deng, Yimei Feng, Lu Zhao, Lidan Zhu, Shuhan Tang, Sanbin Wang, Huanfeng Liu, Peiyan Kong, Hongyun Xing, Xiaoning Wang, Lu Wang, Jia Liu, Xi Zhang, Ting Chen, Linhui Wang, Yuqing Liu, Shifeng Lou, Liangliang Ma, Han Yao, Mingqiang Ren, Tao Lang, Lei Gao, Jishi Wang, Li Li, Xiaoqi Wang, Dan Wang
article en
4 citations

Abstract

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is pivotal for hematological malignancies but faces challenges in delayed platelet engraftment, poor graft function (PGF), and bleeding risks. Hetrombopag, a thrombopoietin receptor agonist, was evaluated to enhance platelet recovery posttransplant. Patients undergoing allo-HSCT were randomized on Day 3 Post-Infusion into low-dose (2.5 mg/day), high-dose (5 mg/day) hetrombopag groups, or a control group receiving thrombopoietin (300 U/kg/day). Endpoints included platelet/neutrophil engraftment time, PGF incidence, transfusion needs, and safety. Among 212 analyzed patients, platelet engraftment was faster in hetrombopag groups (median 13 days) versus controls (15 days; p = 0.0022), with no dose-dependent difference (p = 0.0593). Neutrophil engraftment was also accelerated (13 vs. 15 days; p = 0.0001). PGF incidence was lower in hetrombopag groups (5.04%) versus controls (13.7%; p = 0.027). The experimental group required fewer platelet transfusions (p = 0.002), had reduced gastrointestinal bleeding, and lower costs. Secondary platelet recovery failure showed no intergroup differences. Hetrombopag safely accelerates platelet and neutrophil engraftment, reduces PGF risk, and decreases transfusion dependency post-allo-HSCT. Low-dose hetrombopag demonstrated efficacy equivalent to high-dose, offering a cost-effective strategy to improve transplant outcomes. Trial Registration: ChiCTR2200057764.

American Journal of HematologyVol. 100(9)
Guiyang Medical University (CN), Army Medical University (CN), Zunyi Medical University (CN), Dalian Medical University (CN), Affiliated Hospital of Southwest Medical University (CN), Second Affiliated Hospital of Chongqing Medical University (CN), Chengdu Military General Hospital (CN), Affiliated Hospital of Guizhou Medical University (CN), First Affiliated Hospital of Xi'an Jiaotong University (CN), People's Hospital of Xinjiang Uygur Autonomous Region (CN), First Affiliated Hospital of Dalian Medical University (CN), Guizhou Provincial People's Hospital (CN), Chongqing Medical University (CN)
National Natural Science Foundation of China
Good health and well-being
Openalex Percentile: Top 3%
Platelet Disorders and Treatments
7.08
DOISourceOpenAlex
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