Early Prophylactic rhTPO Administration for Thrombocytopenia Associated With EAP Regimen-Based Hematopoietic Stem Cell Mobilization

Summary

This is a multicenter, prospective, single-arm, phase II clinical study evaluating the early prophylactic use of recombinant human thrombopoietin (rhTPO) to prevent thrombocytopenia associated with the EAP regimen for hematopoietic stem cell mobilization. The EAP regimen consists of etoposide, cytarabine, and pegylated granulocyte colony-stimulating factor (pegfilgrastim) and is used for hematopoietic stem cell mobilization before autologous stem cell transplantation in patients with multiple myeloma and B-cell lymphoma. Severe thrombocytopenia is a common complication during EAP-based stem cell mobilization and may increase the risk of bleeding and the need for platelet transfusions, and may sometimes delay stem cell collection. In this study, patients whose platelet counts decrease to ≤80 × 10⁹/L after EAP chemotherapy will receive rhTPO early as a preventive treatment. The study will evaluate whether early rhTPO administration can reduce the incidence of clinically significant bleeding and the need for platelet transfusion while maintaining adequate hematopoietic stem cell mobilization. The study will also monitor platelet counts, stem cell collection outcomes, and treatment-related adverse events to evaluate the effectiveness and safety of early rhTPO administration.

Timeline

Start

2027-01-01

Primary completion

2029-12-31

Completion

2030-12-01

Drugs

Indications