Transplant Clinical Trial
Official title:
Reactivation of EBV for Patients With CAEBV and EBV Associated HLH After Transplantation
PD-1 antibody for reactivation of EBV after transplantation in patients with CAEBV/EBV-HLH
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | January 1, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; EBV-DNA in peripheral blood or EBER in tissue were positive, patients were diagnosed with EBV associated HLH (EBV-HLH). Chronic active EBV infection (CAEBV) was diagnosed by WHO criteria. 2. Undergo allo-HCT, have achieved full chimerism 3. Age >18 years old, gender is not limited. 4. After transplantation, EBV was reactivated and EBV-DNA was positive in blood 5. No secondary graft failure. (After grafted, ANC <0.5*10^9/l,PLT <10*10^9/l) 6. No uncontrollable infection 7. Withdraw immunosuppressor, no graft-versus-host disease was observed. 8. Before the start of the study, aminopherase (ALT/AST) and total bilirubin were normal. Serum creatinine = 1.5 times the upper limit of Normal (ULN); No thyroid dysfunction. The left ventricular ejection fraction (LVEF) was normal. 9. Informed consent. Exclusion Criteria: 1. Allergic to toripalimab 2. Serious immunoreaction: myocardial damage, hepatitis, pneumonia 3. Central nervous system symptoms 4. Serious mental illness; 5. Active bleeding of the internal organs 6. Pancreatitis history. Patients unable to comply during the trial and/or follow-up phase; 7. Participate in other clinical research at the same time. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Friendship Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Survival | From enrollment until death or the end of the experiment | 1 year | |
Primary | EBV-DNA turn negative | after treatment, the EBV-DNA copies can not be detected in peripheral blood | 4 weeks after PD-1 antibody was used | |
Secondary | treatment-related adverse events as assessed by CTCAE v5.0 | Adverse events including thyroid function,liver function damage, myelosuppression, infection, bleeding and so on | 4 weeks after PD-1 antibody was used |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05047068 -
OCS Heart Perfusion Post-Approval Registry
|
||
Completed |
NCT03455062 -
Fertility Study of Women Who Received Organ Transplantation
|
N/A | |
Terminated |
NCT05033548 -
Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient
|
||
Recruiting |
NCT04182607 -
Donor Outcomes Following Hand-Assisted And Robotic Living Donor Nephrectomy: A Retrospective Review
|
||
Completed |
NCT01022905 -
Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients
|
Phase 4 | |
Completed |
NCT00436384 -
Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients
|
Phase 4 | |
Active, not recruiting |
NCT03691220 -
Improving Medication Adherence in Adolescents Who Had a Liver Transplant
|
N/A | |
Completed |
NCT00571818 -
The Prospective Evaluation of Pancreatic Function in Pancreas Transplant Recipients
|
N/A | |
Terminated |
NCT00884039 -
Anecortave Acetate Injection to Treat Steroid-responsive Intraocular Pressure Increase in Cornea Transplant Patients
|
N/A | |
Completed |
NCT00677677 -
Safety and Immunogenicity of Human Papillomavirus (HPV) Vaccine in Solid Organ Transplant Recipients
|
Phase 3 | |
Completed |
NCT03860818 -
Improving Transplant Medication Safety Through A Technology and Pharmacist Intervention
|
N/A | |
Recruiting |
NCT04626167 -
Concomitant Renal and Urinary Bladder Allograft Transplantation
|
Early Phase 1 | |
Completed |
NCT01389804 -
Parents of Pediatric Solid Organ Transplant Recipients: Transition to Home and Chronic Illness Care
|
N/A | |
Recruiting |
NCT04390724 -
Optimizing Y90 Therapy for Radiation Lobectomy
|
||
Active, not recruiting |
NCT00152802 -
Pneumonia Vaccine in Liver Transplant Recipients: a Booster Strategy Using a Conjugate Vaccine
|
Phase 4 | |
Not yet recruiting |
NCT05951231 -
Liver Transplantation After ex Vivo Liver Perfusion
|
N/A | |
Completed |
NCT00242099 -
Clinical Utility of Monitoring for Human Herpesvirus-6 (HHV-6) and Human Herpesvirus-7 (HHV-7) After Liver Transplant
|
Phase 4 | |
Recruiting |
NCT05717842 -
Simultaneous Prospective Kidney Transplant Assessment in Combined Liver Kidney Candidates
|
||
Active, not recruiting |
NCT05655546 -
ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals
|
N/A | |
Recruiting |
NCT06161454 -
Xofluza-Wearables Feasibility-Study
|
Phase 4 |