RecruitingPhase 2NCT07570745

Low-Dose ATG/PTCy Plus Ivarmacitinib for aGVHD Prevention in Haplo-PBSCT From Parous Female Donors

Low-Dose ATG/PTCy Plus Ivarmacitinib to Prevent Acute Graft-versus-Host Disease Following Haploidentical Peripheral Blood Stem Cell Transplantation From Parous Female Donors: A Prospective, Single-Arm, Multicenter Trial


Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

82 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Graft-versus-host disease (GVHD) is a major complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT), significantly affecting survival and quality of life. Acute GVHD (aGVHD) typically occurs within 100 days post-transplant, commonly involving skin, gastrointestinal tract, and liver. Chronic GVHD (cGVHD) can appear months to years later. Despite prophylaxis with calcineurin inhibitors (e.g., cyclosporine or tacrolimus), methotrexate, mycophenolate mofetil, and post-transplant cyclophosphamide (PTCy), patients receiving haploidentical transplantation from parous female donors remain at high risk for moderate-to-severe aGVHD. JAK1-dependent cytokine signaling (IL-6, IFN-γ) is central to GVHD pathogenesis. Selective JAK1 inhibition may attenuate T cell-mediated inflammation while preserving hematopoiesis. Ivarmacitinib (SHR0302) is a highly selective oral JAK1 inhibitor, showing favorable safety and preliminary efficacy in autoimmune and GVHD settings, making it a candidate for early GVHD prophylaxis.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Low-dose ATG + PTCy + Ivarmacitinib for people with bone marrow transplantation and graft-versus-host-disease (gvhd). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow-dose ATG + PTCy + Ivarmacitinib

Patients will receive rabbit ATG 2.5 mg/kg on Day -2 and -1 (total 5 mg/kg), post-transplant cyclophosphamide 50 mg/kg on Day +3, cyclosporine/MMF starting Day +4, and Ivarmacitinib 4 mg PO daily from Day -3 to +45, reduced to 2 mg PO daily from Day +46 to +60


Locations(1)

Shanghai General Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

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NCT07570745


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