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.
Age between 18 and 70 years (inclusive) at the time of signing the Informed Consent Form (ICF).
ECOG Performance Status score of 0 or 1, with no deterioration over the preceding two weeks.
Life expectancy of at least 12 weeks.
Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)
Known active or latent tuberculosis, evidenced by a positive tuberculin (PPD) skin test (where a positive result is defined as an induration >10 mm or per local clinical standards) or findings suggestive of active/latent TB on chest X-ray/CT.
Known history of Human Immunodeficiency Virus (HIV) infection and/or AIDS.
For hepatitis B virus (HBV): Subjects who are HBV DNA positive are excluded. Subjects with undetectable HBV DNA levels are eligible. The upper limit of normal (ULN) for HBV DNA is determined by the local laboratory at each center.
For hepatitis C virus (HCV): Subjects who are HCV RNA positive are excluded. Subjects with undetectable HCV RNA are eligible. The ULN for HCV RNA is determined by the local laboratory at each center.
The patients with peripheral T-cell lymphoma that has achieved complete response (CR) after first-line therapy.
Cohort
Prospective
Autologous Hematopoietic Stem Cell Transplantation
Procedure/SurgeryAuto-HSCT involves the infusion of the patient's own previously collected stem cells.
Observation
Other interventionThis is a patient cohort that receives monitoring after first-line therapy with complete response.
event-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.
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.
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.
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.
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