Allo-HSCT Vs. Auto-HSCT for PTCL Patients With PR After First-line Systemic Therapy : A Prospective, Multicenter, Cohort Study-(T-START-PR)

Exclusion Criteria

• •1. Ann Arbor clinical stage I disease.
• •2. 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).
• •3. Active infection, including:
• •1. 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.
• •2. Known history of infection with Human Immunodeficiency Virus (HIV) and/or AIDS.
• •3. Chronic active hepatitis B or hepatitis C infection:
• •<!-- -->
• •1. Patients positive for hepatitis B virus (HBV) DNA are excluded; however, those with undetectable HBV DNA levels are eligible. The upper limit of normal (ULN) for HBV DNA shall be based on the reference values of each participating center.
• •2. Patients positive for hepatitis C virus (HCV) RNA are excluded; however, those with undetectable HCV RNA are eligible. The ULN for HCV RNA shall be based on the reference values of each participating center.
• •(d) Active viral infections other than hepatitis B or hepatitis C (e.g., herpes zoster, cytomegalovirus).
• •(e) Infection requiring intravenous antimicrobial therapy, associated with hemodynamic instability, worsening or new onset of infectious signs/symptoms, or new infectious foci on imaging; or persistent fever without localizing signs that cannot rule out infection.
• •(f) Positive serum DNA test for Epstein-Barr virus (EBV).
• •4. Poorly controlled cardiac symptoms or disease, such as:
• •i. Heart failure greater than New York Heart Association (NYHA) class II. ii. Unstable angina. iii. Myocardial infarction within the past year. iv. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
• •5. Pregnant or lactating women, and subjects of childbearing potential unwilling to use effective contraception.
• •6. Psychiatric illness or individuals unable to provide informed consent.
• •7. PTCL patients with central nervous system involvement.
• •8. PTCL patients who have previously received PD-1 inhibitor therapy.
• •9. Any other condition that, in the judgment of the investigator, would make the subject unsuitable for participation in this study.