RecruitingNCT07253129

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

Allogeneic Hematopoietic Stem Cell Transplantation Versus Autologous Hematopoietic Stem Cell Transplantation for Peripheral T-cell Lymphoma Patients With Partial Remission After First-line Systemic Therapy : A Prospective, Multicenter, Cohort Study(T-START-PR)


Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

88 participants

Start Date

Dec 31, 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 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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This prospective study compares two types of stem cell transplant strategies — one using a donor's cells (allogeneic HSCT) versus the patient's own cells (autologous HSCT) — for patients with a type of T-cell lymphoma (PTCL) that only partially responded to first-line chemotherapy, to determine which approach leads to better long-term outcomes. **You may be eligible if...** - You are between 18 and 70 years old - You have a confirmed diagnosis of specific types of PTCL (such as PTCL-NOS, ALK-negative ALCL, or follicular T-cell lymphoma) - You achieved a partial response (not a full response) after 6 cycles of standard chemotherapy - Your heart, lung, liver, and kidney function meet required levels - A suitable stem cell donor is available (for the allogeneic group) - Your expected survival is greater than 12 weeks **You may NOT be eligible if...** - Your lymphoma is at an early stage (Stage I) - You have another cancer in the past 5 years (with limited exceptions) - You have an active infection (including HIV, active tuberculosis, or active hepatitis B or C) - You have poorly controlled heart problems - You are pregnant or breastfeeding - Your lymphoma has spread to the central nervous system (brain or spinal cord) - You have previously received a PD-1 inhibitor (a type of immune checkpoint drug) 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.

PROCEDUREAllogenic stem cell transplant (ASCT)

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


Locations(1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

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NCT07253129


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