Baricitinib for Post-HSCT Persistent Thrombocytopenia (NCT07535645) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Baricitinib for Post-HSCT Persistent Thrombocytopenia
China28 participantsStarted 2026-04-15
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Aged 18-70 years;
* Underwent allo-HSCT;
* Meet the diagnostic criteria for delayed platelet engraftment (DPE) or secondary failure of platelet recovery (SFPR);
* Have platelet counts consistently \<20 ×10\^9/L or transfusion-dependent within 14 days prior to enrollment;
* Have received adequate corticosteroid and TPO-RA therapy for persistent thrombocytopenia for no less than 4 weeks, with treatment failure or intolerance;
* Complete donor chimerism.
Exclusion Criteria:
* Relapse of hematologic malignancy or MRD positivity;
* Active infection;
* Active graft-versus-host disease;
* Thrombotic microangiopathy;
* Primary graft failure or poor graft function;
* Presence of other factors that may lead to secondary thrombocytopenia at the time of PT diagnosis;
* History of systemic herpes zoster infection within 12 weeks prior to enrollment screening;
* Acute or chronic infection with HBV, HCV, or HIV;
* Evidence of active tuberculosis, or history of active tuberculosis without documented standard anti-tuberculosis treatment, or close contact with active tuberculosis without documented standard tuberculosis prophylaxis;
* Receipt of a live vaccine within 12 weeks prior to enrollment screening, or planned receipt of a live vaccine during the study period;
* Clinically significant thromboembolic event within 24 weeks prior to enrollment screening, or current use of anticoagulant medications deemed by the investigator to carry an uncontrollable risk;
* Estima…