This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the allogeneic hematopoietic stem cell transplantation group (Allo-HSCT) and the autologous hematopoietic stem cell transplantation group (Auto-HSCT). It aims to evaluate the efficacy and safety of Auto-HSCT and Allo-HSCT in the treatment of peripheral T-cell lymphoma that has achieved partial response (PR) after first-line therapy. During the screening/baseline period, informed consent will be obtained, and inclusion/exclusion criteria will be verified. Group assignment (Allo-HSCT vs. Auto-HSCT) will be determined taking into account the availability of a matched donor and the patient's preference. The study plans to enroll 44 patients in the allogeneic hematopoietic stem cell transplantation group, while all concurrent patients undergoing autologous stem cell transplantation will be included in the other group for inverse probability weighting analysis. 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.
ECOG performance status score of 0 to 1, with no deterioration within the last two weeks.
Expected survival period greater than 12 weeks.
Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)
Anaplastic large cell lymphoma, ALK-negative (ALK-ALCL)
Ann Arbor clinical stage I disease.
History of malignancy within the past 5 years, except for locally curable malignancies that have been treated with curative intent (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).
Known active or latent tuberculosis, evidenced by a positive tuberculin (PPD) skin test (induration >10 mm or per local criteria for a positive result) or radiographic findings suggestive of active/latent TB on chest X-ray/CT.
Known history of infection with Human Immunodeficiency Virus (HIV) and/or AIDS.
Patients with PTCL who are in PR following first-line therapy and who are both medically eligible and willing to undergo transplantation will be directly assigned to treatment with either allogeneic PBSCT or autologous HSCT.
Cohort
Prospective
Autologous Hematopoietic Stem Cell Transplantation
Procedure/SurgeryAuto-HSCT involves the infusion of the patient's own previously collected stem cells.
Allogenic stem cell transplant (ASCT)
Procedure/SurgeryASCT involves the infusion of stem cells collected from a donor (genetically similar, but not identical).
2y-event-free survival (EFS)
2-year 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.
3m and 6m-complete response rate
The duration from the date of hematopoietic stem cell transplantation to the first occurrence of complete response.
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.
1y and 2y-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.
non-relapse mortality (NRM)
Death occurring after transplantation due to causes other than disease relapse, such as infection, organ toxicity, or transplantation-related complications. Deaths from any cause in the absence of prior relapse are considered events for this endpoint
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