Acute lymphoblastic leukemia
Conditions
Interventions
Group A:thiotepa, fludarabine plus busulfan regimen as conditioning regimen prior to allo-HSCT
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-65, regardless of gender or race. 2. Diagnosed with acute lymphoblastic leukemia according to the WHO 2022 criteria. 3. Planning to undergo allogeneic hematopoietic stem cell transplantation and must have a suitable stem cell donor. 4. Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) = 2. 5. Eastern Cooperative Oncology Group (ECOG) performance status = 2. 6. Good organ function levels: 1) Serum creatinine = 1.5×ULN; 2) Cardiac function: Ejection fraction = 50%; 3) Baseline oxygen saturation >92%; 4) Total bilirubin = 1.5×ULN; ALT and AST = 2.0×ULN; 5) Pulmonary function: DLCO (corrected for hemoglobin) = 40% and FEV1 = 50%. 7. Patients must be capable of understanding and willing to participate in this study, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Within the past 5 years prior to screening, having had malignancies other than acute lymphoblastic leukemia, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery; 2. ECOG score > 2; 3. HCT-CI score = 3; 4. Any unstable systemic diseases, including but not limited to unstable angina, cerebrovascular accident or transient ischemic attack (within 3 months prior to screening), myocardial infarction (within 3 months prior to screening), congestive heart failure (New York Heart Association [NYHA] class = III), serious arrhythmias requiring drug therapy after pacemaker implantation, hepatic, renal, or metabolic diseases, pulmonary arterial hypertension; 5. Active, uncontrolled infections: associated with hemodynamic instability due to infection, or presenting with new infection symptoms or signs worsening, or new infectious lesions detected by imaging, or persistent fever without symptoms or signs suggestive of infection that cannot be ruled out; 6. Severe conditions requiring treatment such as grade = 2 epilepsy, paralysis, aphasia, new-onset cerebral infarction, severe traumatic brain injury, dementia, Parkinson's disease, schizophrenia; 7. Human immunodeficiency virus (HIV) infection; 8. Patients requiring antiviral treatment for active hepatitis B virus (HBV) or active hepatitis C virus (HCV); patients at risk of HBV reactivation, defined as those who are hepatitis B surface antigen positive or core antibody positive and have not received antiviral therapy for HBV; 9. History of autoimmune diseases; 10. Pregnant or lactating females; 11. Fertile males and females unwilling to use contraception during treatment and for 12 months after treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year, 2 years Disease-Free Survival (DFS) post-transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative relapse rates at 1 year and 2 years post-transplantation;Overall Survival (OS) at 1 year and 2 years post-transplantation;Incidence of acute GVHD within 180 days post-transplantation;Cumulative incidence of chronic GVHD;Graft-versus-Host Disease (GVHD)-free, relapse-free survival (GRFS);Non-relapse mortality (NRM);Toxicity within 2 years post-transplantation; | — |
Countries
China
Contacts
Public ContactJiejing Qian, Hongyan Tong
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed