RecruitingNot ApplicableNCT06509945

Allo-PBSCT as the First-line Treatment for Patients With the High-risk PTCL

Allogeneic Peripheral Blood Stem Cell Transplantation as the First-line Treatment for Patients With the High-risk Peripheral T Cell Lymphoma


Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

50 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-center, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of allogeneic peripheral blood stem cell transplantation in the treatment of high-risk peripheral T-cells lymphoma patients achieved complete response (CR) or partial response (PR). Conventional conditioning regimen is adopted while the reduced-intensity conditioning regimens will be preferred. Donor hematopoietic stem cell infusion is performed on day 0. All patients will undergo bone marrow examination on day 14 and day 28 post-transplant, followed by bone marrow examinations every 30 days within the first year after transplantation, and every 60 days within the second year after transplantation. Positron emission tomography with 2-deoxy-2-\[fluorine-18\]fluoro-D-glucose integrated with computed tomography (18F-FDG PET/CT) imaging will be performed every 6 months after transplantation. If disease relapse is suspected during the follow-up period, bone marrow and relapse site examinations will be conducted at any time. The primary study endpoints are the 1-year and 2-year progression-free survival (PFS) rates post-transplant. Secondary study endpoints include the incidence of acute graft-versus-host disease (GVHD) within 180 days post-transplant, cumulative relapse rates at 1 year and 2 years post-transplant, 1-year and 2-year overall survival (OS), graft-versus-host disease-free, relapse-free survival (GRFS), non-relapse mortality (NRM), cumulative incidence of chronic GVHD, and the incidence of Cytomegalovirus (CMV)and Epstein-Barr virus(EBV)reactivation within 1 year.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an early allogeneic stem cell transplant (using donor cells) as a first-line treatment — after initial chemotherapy achieves remission — can improve outcomes for patients with high-risk peripheral T-cell lymphoma (PTCL), a type of aggressive blood cancer. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with peripheral T-cell lymphoma classified as high-risk (IPI score ≥ 3 or age-adjusted IPI ≥ 2) - Your cancer achieved complete or partial remission after first-line chemotherapy - You meet the fitness criteria for a stem cell transplant **You may NOT be eligible if...** - Your cancer did not respond to initial chemotherapy - You are older than 70 years - You are not healthy enough to undergo a stem cell transplant - You have other serious organ problems 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

OTHERallogeneic peripheral blood stem cell transplantation

Patients achieved response to treatment will receive allogeneic peripheral blood stem cell transplantation.


Locations(1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

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NCT06509945


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