This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the allogeneic hematopoietic stem cell transplantation group (Allo-HSCT) and the alternative salvage regimens. It aims to evaluate the efficacy and safety of Allo-HSCT and alternative salvage regimens in the treatment of peripheral T-cell lymphoma that has achieved no response (NR) 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. alternative salvage regimens) will be determined taking into account the availability of a matched donor and the patient's preference. The study plans to enroll 29 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.
At the time of ICF signing, the subject must be 18-70 years of age, inclusive, regardless of gender.
The subject must have achieved Stable Disease (SD) or Progressive Disease (PD) as assessed per the Lugano 2014 classification criteria after first-line systemic standard therapy (CHOP or a CHOP-like regimen). This includes subjects who failed to achieve a response after at least 4 cycles of standard chemotherapy or who experienced disease progression during treatment.
Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score ≤ 2.
ECOG Performance Status score of 0 or 1, with no deterioration over the preceding two weeks.
Ann Arbor Stage I disease.
History of any other malignancy within the past 5 years, except for locally cured malignancies after radical therapy (e.g., basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).
Known active or latent tuberculosis, indicated by a positive tuberculin (PPD) skin test (defined as induration >10 mm or per local clinical criteria) or radiographic findings on chest X-ray/CT suggestive of active/latent TB.
Known history of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
The patients with peripheral T-cell lymphoma that has achieved no response (NR) after first-line therapy.
Cohort
Prospective
Allogenic stem cell transplant (ASCT)
Procedure/SurgeryASCT involves the infusion of stem cells collected from a donor (genetically similar, but not identical).
Salvage Therapy
Procedure/SurgeryThis term encompasses a range of potential alternative regimens instead of allogeneic hematopoietic stem cell transplantation
2y-overall survival (OS)
The probability of survival at 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.
2y-progression-free survival (PFS)
Progression-Free Survival (PFS) is defined as the time from transpalntation until the first occurrence of disease progression or death from any cause, whichever occurs earlier.
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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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborator
Shanghai Cancer Centre
Collaborator
Ruijin Hospital
Collaborator
