RecruitingNCT07353840

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


Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

160 participants

Start Date

Jan 20, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment strategy for people with a type of aggressive blood cancer called peripheral T-cell lymphoma (PTCL) who have achieved a complete remission (no detectable cancer) after their first round of chemotherapy. Researchers want to find the best next step — such as stem cell transplant or observation — to prevent the cancer from coming back. **You may be eligible if:** - You are aged 18 to 70 - You have been diagnosed with PTCL, ALK-negative ALCL, or PTCL with a TFH phenotype — confirmed by a central lab - You achieved a complete response (cancer completely cleared) after first-line chemotherapy (CHOP or similar) - Your heart, liver, and kidney function are adequate - Your heart pumping function (ejection fraction) is 50% or higher - Your general health is good (ECOG performance status 0 or 1) **You may NOT be eligible if:** - Your cancer is at stage I only - You have had another cancer in the past 5 years (with some exceptions) - You have active infections including HIV, active tuberculosis, or active hepatitis B or C - You have serious heart problems (e.g., heart failure, recent heart attack, severe arrhythmia) - You are pregnant or breastfeeding - You have a psychiatric condition preventing informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAutologous Hematopoietic Stem Cell Transplantation

Auto-HSCT involves the infusion of the patient's own previously collected stem cells.

OTHERObservation

This is a patient cohort that receives monitoring after first-line therapy with complete response.


Locations(1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

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NCT07353840


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