relapsed acute T-lymphoid leukemia/lymphoma after allogeneic hematopoietic stem cell transplantation
Conditions
Interventions
C-P group: cedaraniline and PD-1 antibody (C-P regimen)
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Acute T-lymphoid leukemia/lymphoma must be diagnosed before admission (mainly including peripheral T cell lymphoma, NK/T cell lymphoma, T-cell lymphoblastic lymphoma, etc.). The diagnostic criteria refer to the 2016 WHO classification. 2) Age: 12-70 years old; 3) Relapse after allogeneic hematopoietic stem cell transplantation; 4) The degree of donor chimerism at the time of recurrence is > 30%; 5) Stop immunosuppressant for at least 1 week; 6) The Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0-2 points; 7) Creatinine clearance rate >= 60 mL/min (according to Cockcroft-Gault formula); 8) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 50%; 10) Life expectancy > 8 weeks; 11) Sign the informed consent form voluntarily, understand and comply with the research requirements.
Exclusion criteria
Exclusion criteria: 1) Relapse within 120 days after transplantation; 2) Patients who have received PD-1 antibody or PD-L1 antibody treatment before; 3) Active grade 2-4 acute graft-versus-host disease or active moderate to severe chronic graft-versus-host disease that requires more than 0.25 mg/kg prednisone to control; 4) Active autoimmune diseases such as SLE, rheumatoid arthritis, etc; 5) Currently suffering from clinically significant active cardiovascular diseases such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 determined by the New York Heart Association (NYHA) functional classification Grade heart disease, or a history of myocardial infarction 6 months before screening; 6) Other serious diseases that may restrict patients from participating in this trial (such as advanced infections, uncontrollable diabetes); 7) Human immunodeficiency virus (HIV) infection, or chronic infection of hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive) that cannot be controlled by drugs; 8) Pregnant or lactating women; 9) Those who cannot understand or follow the research plan or cannot sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;overall survival; | — |
Countries
China
Contacts
Public ContactHe Huang
The First Affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed