A Novel JAK1 Inhibitor SHR0302 Combined With Prednisone for First-Line Treatment of Chronic Graft-Versus-Host Disease: A Phase I Clinical Trial.
Qiaomei He, Xi Sun, Jiahua Niu...
https://pubmed.ncbi.nlm.nih.gov/38798038Actively Recruiting
Phase 2
Age: 18Years - 70Years
All Genders
ID07570745
Low-Dose ATG/PTCy Plus Ivarmacitinib to Prevent Acute Graft-versus-Host Disease After Haploidentical Peripheral Blood Stem Cell Transplant 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Graft-versus-host disease (GVHD) is a serious complication after allogeneic hematopoietic stem cell transplantation, affecting survival and quality of life. Acute GVHD usually occurs within 100 days post-transplant, involving the skin, gastrointestinal tract, and liver, while chronic GVHD can develop months to years later. Despite current treatments like calcineurin inhibitors and post-transplant cyclophosphamide, recipients of haploidentical transplants from parous female donors remain at high risk for moderate-to-severe acute GVHD. This trial studies the effect of adding a selective JAK1 inhibitor, Ivarmacitinib, to standard low-dose ATG and cyclophosphamide to reduce GVHD in this high-risk group. Participants will receive rabbit anti-thymocyte globulin (ATG) at 2.5 mg/kg on days -2 and -1 before transplant, cyclophosphamide 50 mg/kg on day +3, and begin cyclosporine and mycophenolate mofetil on day +4. Ivarmacitinib, an oral JAK1 inhibitor, will be given at 4 mg daily from day -3 to +45, then reduced to 2 mg daily from day +46 to +60. This combination aims to prevent acute GVHD while preserving necessary immune functions. The study is a prospective, single-arm, multicenter trial focused on haploidentical peripheral blood stem cell transplantation from parous female donors. During the study, participants will be monitored for acute GVHD incidence up to 180 days post-transplant, graft failure by day 28, and non-relapse mortality by day 180. Assessments include regular clinical evaluations, laboratory tests, and safety monitoring. Participants are expected to comply with follow-up visits and related examinations throughout the study duration. The trial seeks to improve GVHD prevention and overall transplant outcomes in this high-risk population.
CONDITIONS
Brief Title
Low-Dose ATG/PTCy Plus Ivarmacitinib for aGVHD Prevention in Haplo-PBSCT From Parous Female Donors
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years, any gender
- Diagnosed with hematologic malignancies such as 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 donor screening
- Karnofsky performance status of 70 or higher
- Adequate organ function: normal cardiac and pulmonary function; liver enzymes ALT/AST less than 2 times upper limit; total bilirubin less than 1.5 times upper limit; creatinine clearance greater than 50 mL/min
- No active infection prior to transplantation or infection effectively controlled
- Stable chronic infections such as HBV, HCV, or syphilis under treatment; HBV DNA negative or receiving antiviral therapy acceptable
- No significant psychiatric disorders; able to understand and voluntarily consent
- Signed informed consent and agrees to comply with follow-up and examinations
You will not qualify if you...
- Prior hematopoietic stem cell transplantation (autologous or allogeneic)
- Presence of donor-specific antibodies with mean fluorescence intensity 5000 or higher
- History of severe allergy to JAK inhibitors or investigational drug
- Prior treatment with JAK1/2 inhibitors
- Uncontrolled comorbidities such as hypertension, diabetes complications, or active gastrointestinal bleeding increasing risk
- Receipt of other investigational drugs within 2 weeks prior to transplantation (excluding standard chemotherapy)
- Simultaneous participation in other interventional clinical studies
- Any condition deemed unsuitable by investigator including poor compliance or inability to complete follow-up due to psychiatric disorders
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - 2 days
Participants receive low-dose rabbit ATG before transplantation.
2 visits (in-person) on Day -2 and Day -1
Treatment
Duration - Approximately 63 days (Day -3 to Day +60)
Participants undergo haploidentical peripheral blood stem cell transplantation and receive post-transplant cyclophosphamide, cyclosporine/MMF, and Ivarmacitinib for acute GVHD prevention.
Daily oral medication from Day -3 to Day +60 with specific dosing changes; visits on Day +3 and Day +4 for additional treatments
Follow-up
Duration - Up to 180 days post-transplant
Participants are monitored for acute graft-versus-host disease and other outcomes up to 180 days post-transplant.
Regular visits for assessments up to Day +180
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 210000
Actively Recruiting
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Research Team
X
Xianmin Song, PhD
X
Xianmin Song, PhD
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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Published Research Related To This Trial
Preventive and Therapeutic Effects of a Novel JAK Inhibitor SHR0302 in Acute Graft-Versus-Host Disease.
Xi Sun, Qiaomei He, Jun Yang...
https://pubmed.ncbi.nlm.nih.gov/34269100A phase 1 trial of itacitinib, a selective JAK1 inhibitor, in patients with acute graft-versus-host disease.
Mark A Schroeder, H Jean Khoury, Madan Jagasia...
https://pubmed.ncbi.nlm.nih.gov/32324888Baricitinib prevents GvHD by increasing Tregs via JAK3 and treats established GvHD by promoting intestinal tissue repair via EGFR.
Sena Kim, Kidist Ashami, Sora Lim...
https://pubmed.ncbi.nlm.nih.gov/34304247Impact of donor and recipient sex and parity on outcomes of HLA-identical sibling allogeneic hematopoietic stem cell transplantation.
Alison W Loren, Greta R Bunin, Christian Boudreau...
https://pubmed.ncbi.nlm.nih.gov/16785065Randomized trial of GvHD Prophylaxis in Haploidentical PBSC Transplantation: ATG, PTCy, and Low-Dose Combination Therapy.
Jun Yang, Yannan Jia, Xiaoxia Hu...
https://pubmed.ncbi.nlm.nih.gov/41849227Low dose anti-thymocyte globulin with low dose posttransplant cyclophosphamide (low dose ATG/PTCy) can reduce the risk of graft-versus-host disease as compared with standard-dose anti-thymocyte globulin in haploidentical peripheral hematopoietic stem cell transplantation combined with unrelated cord blood.
Xiaoqian Xu, Jun Yang, Yu Cai...
https://pubmed.ncbi.nlm.nih.gov/32873913The Biology of Chronic Graft-versus-Host Disease: A Task Force Report from the National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease.
Kenneth R Cooke, Leo Luznik, Stefanie Sarantopoulos...
https://pubmed.ncbi.nlm.nih.gov/27713092Advances in graft-versus-host disease biology and therapy.
Bruce R Blazar, William J Murphy, Mehrdad Abedi
https://pubmed.ncbi.nlm.nih.gov/22576252Graft-versus-host disease.
James L M Ferrara, John E Levine, Pavan Reddy...
https://pubmed.ncbi.nlm.nih.gov/19282026