Actively Recruiting
Low-Dose ATG/PTCy Plus Ivarmacitinib for aGVHD Prevention in Haplo-PBSCT From Parous Female Donors
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-05-06
82
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low-Dose ATG/PTCy Plus Ivarmacitinib for aGVHD Prevention in Haplo-PBSCT From Parous Female Donors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, any gender
- Diagnosed with hematologic malignancies like acute leukemia, myelodysplastic syndrome, or malignant lymphoma
- Planned to undergo haploidentical peripheral blood stem cell transplantation
- Donor must be a haploidentical relative within three degrees of kinship and a parous female aged 18 to 55 years, healthy and cleared by screening
- Karnofsky performance status of 70 or higher
- Normal or acceptable cardiac, pulmonary, liver (ALT/AST <2x upper limit, total bilirubin <1.5x upper limit), and renal function (creatinine clearance >50 mL/min)
- No active infection before transplantation or infection effectively controlled
- Stable chronic infections such as HBV, HCV, or syphilis under treatment; HBV DNA negative or on antiviral therapy accepted
- No significant psychiatric disorders and able to understand and consent voluntarily
- Signed informed consent and agrees to follow-up and examinations
You will not qualify if you...
- History of prior hematopoietic stem cell transplantation (autologous or allogeneic)
- Presence of donor-specific antibodies with mean fluorescence intensity ≥5000
- Severe allergies or hypersensitivity to JAK inhibitors or the study drug
- Prior treatment with JAK1/2 inhibitors
- Uncontrolled comorbidities before transplantation such as uncontrolled hypertension, diabetes complications, or active gastrointestinal ulcer bleeding
- Use of other investigational drugs within 2 weeks before transplantation (excluding standard chemotherapy)
- Participation in other interventional clinical studies simultaneously
- Any condition the investigator considers unsuitable for participation, including poor compliance or inability to complete follow-up due to psychiatric disorders or other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 210000
Actively Recruiting
Research Team
X
Xianmin Song, PhD
CONTACT
X
Xianmin Song, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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