Adult acute T lymphoblastic leukemia /T lymphoblastic lymphoma
Conditions
Interventions
Intervention group:Combination therapy with citarabine and azacitidine
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Patients after allogeneic haematopoietic stem cell transplantation for acute T-lymphoblastic leukaemia/T-lymphoblastic lymphoma; patients diagnosed with acute T-lymphoblastic leukaemia/T-lymphoblastic lymphoma according to WHO diagnostic criteria; 2. At the time of signing the informed consent form, the following major organ functions need to be fulfilled: (1) Cardiac ultrasound left ventricular ejection fraction >= 50%; (2) Creatinine 91% without oxygen Oxygen saturation > 91% without oxygen. 3. Voluntarily sign the informed consent form; 4. Age 18-60 years old, gender is not limited; 5. Women of childbearing age must have a negative serum pregnancy test within one week prior to the first dose of study drug and use an effective method of contraception (e.g., IUD, birth control pills, or condoms) during the study period and for 90 days after the last dose of study drug; for men, they should be surgically sterilised or agree to use an effective method of contraception during the study period and for 90 days after the last dose of study drug; 6. an ECOG score of 0-2; 7. expected survival greater than 3 months.
Exclusion criteria
Exclusion criteria: 1. Concurrent malignant tumours; 2. Concurrent acute or chronic graft-versus-host disease (GVHD) at enrolment; 3. Morphological or molecular recurrence, extramedullary recurrence, including central nervous system leukaemia or extramedullary infiltration; 4. Previous therapeutic intervention with other medicinal products post-transplantation; 5. Known history of hepatitis B (HBsAg positive) or hepatitis C (HCV antibody positive). Subclinical or pre-carrier phase hepatitis B infection (defined as HBcAb positive, HBsAg negative) may be included if HBV DNA PCR is negative; such subjects require monthly HBV DNA PCR monitoring. Serologically HCV antibody-positive subjects may be enrolled if HCV RNA PCR testing is negative; 6. Presence of bacterial, fungal, viral, mycoplasmal, or other infections deemed difficult to control by the investigator; 7. HIV or syphilis infection; 8. History or current presence of central nervous system (CNS) disorders, such as epileptic seizures, cerebrovascular ischaemia/haemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease; 9. Undergone cardiac angioplasty or stent placement within 12 months prior to signing the informed consent form, or history of myocardial infarction, unstable angina pectoris, or other clinically significant cardiac conditions; 10. Individuals with primary immunodeficiency; 11. History of severe immediate hypersensitivity reaction to any medication to be used in this study; 12. Administration of live vaccines within 6 weeks prior to screening; 13. Pregnant or lactating women; 14. Active autoimmune disease; 15. Any other condition deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CIR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;OS;RFS; | — |
Countries
China
Contacts
Public ContactXiaohui Hu
The First Affiliated Hospital of Soochow University
Outcome results
None listed