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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Autologous Hematopoietic Stem Cell Transplantation
  • Allogenic stem cell transplant (ASCT)

Treatment groups

88 Participants
are divided into 2 treatment groups