NCT07353840

T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-CR

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Autologous Hematopoietic Stem Cell Transplantation	Auto-HSCT involves the infusion of the patient's own previously collected stem cells.
OTHER	Observation	This is a patient cohort that receives monitoring after first-line therapy with complete response.

Timeline

• Start date: 2026-01-20
• Primary completion: 2029-05-30
• Completion: 2029-09-30
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: China