NCT07535645

Baricitinib for Post-HSCT Persistent Thrombocytopenia

Safety and Efficacy of Baricitinib in Thrombopoietin-Receptor-Agonist-Refractory Persistent Thrombocytopenia After Allogeneic Hematopoietic Stem Cell Transplantation: A Phase Ib/II Study

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label phase 1b/2 clinical trial to explore the safety and efficacy profiles of baricitinib in patients with thrombopoietin-receptor-agonist-refractory persistent thrombocytopenia after allogeneic hematopoietic stem cell transplantation.

Detailed description

Phase 1 part: The phase 1b part will use a standard 3+3 design to explore the safety profiles and to establish the recommended phase 2 dose (RP2D) of baricitinib. The initial dose is 2 mg once daily, and the maximum dose is 4 mg once daily. Additional patients may be enrolled to further explore a selected dose defined by dose escalation cohorts (up to 9 patients in each dose level). Phase 2 part: The phase 2 part is a single-arm, open-label study to assess the efficacy and safety of baricitinib at RP2D in patients with thrombopoietin-receptor-agonist-refractory persistent thrombocytopenia after allogeneic hematopoietic stem cell transplantation. Patients in phase 1b who were treated with baricitinib at the RP2D will be included in the phase 2 efficacy endpoint analyses.

Conditions

• Persistent Thrombocytopenia
• Allogeneic Hematopoietic Stem Cell Transplantation

Interventions

Type	Name	Description
DRUG	Baricitinib	Baricitinib, an orally administered, selective, reversible JAK1/2 inhibitor.

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-12-31
• Completion: 2029-09-15
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: China