RecruitingNCT07470996

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


Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

58 participants

Start Date

Oct 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the allogeneic hematopoietic stem cell transplantation group (Allo-HSCT) and the alternative salvage regimens. It aims to evaluate the efficacy and safety of Allo-HSCT and alternative salvage regimens in the treatment of peripheral T-cell lymphoma that has achieved no response (NR) 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. alternative salvage regimens) will be determined taking into account the availability of a matched donor and the patient's preference. The study plans to enroll 29 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 evaluating new treatment strategies for patients with a rare and aggressive blood cancer called peripheral T-cell lymphoma (PTCL) whose disease did not respond to — or came back during — their first round of standard chemotherapy. **You may be eligible if...** - You are between 18 and 70 years old - You have a confirmed diagnosis of PTCL (specifically PTCL-NOS, ALK-negative ALCL, or follicular helper T-cell lymphoma) - Your cancer either did not respond to, or progressed during, at least 4 cycles of standard chemotherapy (CHOP or similar) - You have good physical function (ECOG 0 or 1) and adequate heart, lung, kidney, and liver function - A suitable stem cell donor has been identified for potential transplant **You may NOT be eligible if...** - You have stage I disease (early, limited-spread lymphoma) - You have had another cancer in the past 5 years (except certain fully treated skin cancers or early-stage cancers) - You have active tuberculosis, HIV, active hepatitis B or C, or another active viral infection - You have significant heart failure or recent heart attack - You are pregnant or breastfeeding - You have PTCL with involvement of the central nervous system (brain or spinal cord) - You have previously received PD-1/PD-L1 immunotherapy 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

PROCEDUREAllogenic stem cell transplant (ASCT)

ASCT involves the infusion of stem cells collected from a donor (genetically similar, but not identical).

PROCEDURESalvage Therapy

This term encompasses a range of potential alternative regimens instead of allogeneic hematopoietic stem cell transplantation


Locations(1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

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NCT07470996


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