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RECRUITING
NCT07353840

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

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

160

Start Date

2026-01-20

Completion Date

2029-09-30

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

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.

Locations (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China