To evaluate, through a prospective multicenter observational study, autologous or allogeneic hematopoietic stem cell transplantation (Auto-SCT/allo-SCT)as consolidation therapy in subjects with T lymphoblastic leukemia/Lymphoblastic lymphoma(T-ALL/LBL)who have achieved first complete remission (CR). Assess relapse-free survival (RFS), overall survival (OS), cumulative incidence of relapse (CIR), and non-relapse mortality (NRM) among different treatment regimens
This prospective, multicenter cohort study enrolls patients with T-lymphoblastic leukemia/lymphoma in first complete remission (CR1) to investigate the efficacy and safety of autologous versus allogeneic hematopoietic stem cell transplantation as consolidation therapy. At screening/baseline, informed consent is obtained and inclusion/exclusion criteria are checked. The planned enrollment is 84 patients per group. Data collection includes demographics, medical history, vital signs, physical examination, laboratory tests (cranial MRI with contrast, PET-CT, routine blood and urine tests, liver and kidney function, routine CSF analysis, biochemistry, abnormal cells), pregnancy tests for female patients, and other necessary auxiliary examinations.
Study Type
OBSERVATIONAL
Enrollment
84
cohort study
Relapse free survival
Relapse free survival
Time frame: 24 months
RFS
relapse free survival
Time frame: 12 months
CIR
Cumulative incidence of relapse
Time frame: 12 months
CIR
Cumulative incidence of relapse
Time frame: 24 MONTHS
OS
Overall survival
Time frame: 12 months
OS
Overall survival
Time frame: 24 months
NRM
non-relapse mortality
Time frame: 12 months
NRM
non-relapse mortality
Time frame: 24 months
CI of aGVHD
Cumulative incidence of acute graft-versus-host disease (acute GVHD) for patients undergoing allo-SCT
Time frame: 180 days
CI of cGVHD
Cumulative incidence of chronic graft-versus-host disease (chronic GVHD) after autologous versus allogeneic hematopoietic stem cell transplantation
Time frame: 12 months
CI of cGVHD
Cumulative incidence of chronic graft-versus-host disease (chronic GVHD) after autologous versus allogeneic hematopoietic stem cell transplantation
Time frame: 24 months
Graft failure rate
Graft failure rate
Time frame: 28 days after allo-SCT
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