This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the observation group and the autologous hematopoietic stem cell transplantation group (Auto-HSCT). It aims to evaluate the efficacy and safety of Auto-HSCT and observation in the treatment of peripheral T-cell lymphoma that has achieved complete response (CR) after first-line therapy. During the screening/baseline period, informed consent will be obtained, and inclusion/exclusion criteria will be verified. Group assignment (Observation vs. Auto-HSCT) will be determined taking into account the patient's preference. The study plans to enroll 80 patients in each group. Data on demographics and medical history will be collected, and assessments including vital signs, physical examination, PET-CT, bone marrow aspiration smear, flow cytometry, and bone marrow pathology will be performed.
Study Type
OBSERVATIONAL
Enrollment
160
Auto-HSCT involves the infusion of the patient's own previously collected stem cells.
This is a patient cohort that receives monitoring after first-line therapy with complete response.
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGevent-free survival (EFS)
Event-free survival (EFS) rates post-transplant. An event is defined as whichever of the following occurs first: disease progression, death from any cause, commencement of new anti-tumor therapy, or a treatment-related serious adverse event (specifically including disabling events or secondary neoplasms). Subjects who were event-free at the data cutoff will be censored on the date of their last tumor assessment.
Time frame: up to 2 years for the 2y-EFS
1y and 2y-cumulative relapse rates (CIR)
The cumulative probability of disease progression (including relapse or progression of the primary disease) within 1 or 2 years after transplantation, with non-progression-related death treated as a competing event.
Time frame: up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR
Disease-Free Survival (DFS)
DFS means the time from transplantation until the first occurrence of any of the following events: disease recurrence, disease progression, or death from any cause.
Time frame: up to 1 years for the DFS
overall survival (OS)
The probability of survival at 1 or 2 years, measured from the date of transplantation to death from any cause. Patients who are still alive at the time of analysis will be censored on the last follow-up date.
Time frame: up to 1 years for the 1y-OS and up to 2 years for the 2y-OS
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