Clinical study of recombinant human thrombopoietin in platelet engraftment following autologous hematopoietic stem cell transplantation.

BACKGROUND

Autologous transplantation is an effective treatment for hematological malignancies. However, post-transplant thrombocytopenia is a common complication. This study evaluated the efficacy and safety of recombinant human thrombopoietin (rhTPO) in promoting platelet engraftment following autologous hematopoietic stem cell transplantation (ASCT).

METHODS

A prospective, multicentre, single-arm study screened patients for ASCT at three centers. rhTPO was administered from day +3 to +7 post-ASCT until platelet engraftment. Efficacy was assessed by time to platelet and neutrophil engraftment and platelet transfusion needs. Safety was evaluated via adverse events, hepatic/renal function, and electrolyte balance.

RESULTS

In 63 patients, the median platelet engraftment time was 11 days (range: 8-22) and leukocyte engraftment 9 days (range: 7-15). Pre-transplant platelet count (HR=1.01, P = 0.003) and CD34+ cell dose (HR=1.42, P = 0.008) were independent predictors of platelet engraftment. Furthermore, baseline platelet count ≥ 180 × 10⁹/L and CD34+ cell dose >4.46 × 10⁶/kg reduced engraftment time (P < 0.05). Lymphoma patients required more platelet transfusions (P = 0.002). The non-Chi-CGB group demonstrated higher red blood cell and platelet transfusion volumes (P = 0.042, P = 0.002). Adverse events included elevated transaminases (11.1 %), elevated bilirubin (14.3 %), and thrombosis (1.6 %). The primary adverse bleeding events included skin ecchymosis (25.4 %) and gastrointestinal hemorrhage (4.7 %).

CONCLUSION

It has been demonstrated that rhTPO promotes platelet engraftment in ASCT for hematological malignancies, exhibiting a favorable safety profile. Pre-transplant platelet counts ≥180 × 10⁹/L and CD34+ cell doses >4.46 × 10⁶/kg predict faster platelet engraftment.