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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Patients achieved response to treatment will receive allogeneic peripheral blood stem cell transplantation.
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
RECRUITING1y and 2y-progression-free survival (PFS)
1-year and 2-year progression-free survival (PFS) rates post-transplant
Time frame: up to 1 years for the 1y-PFS and up to 2 years for the 2y-PFS
acute graft-versus-host disease (aGVHD)
acute graft-versus-host disease (aGVHD) within 180 days post-transplant
Time frame: up to 180 days
1y and 2y-cumulative relapse rates (CIR)
cumulative relapse rates (CIR) at 1 year and 2 years post-transplant
Time frame: up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR
1y and 2y-overall survival (OS)
overall survival (OS) at 1 year and 2 years post-transplant
Time frame: up to 1 years for the 1y-OS and up to 2 years for the 2y-OS
graft-versus-host disease-free and relapse-free survival (GRFS)
graft-versus-host disease-free and relapse-free survival (GRFS) at 2 years post-transplant
Time frame: up to 2 years
non-relapse mortality (NRM)
non-relapse mortality (NRM) at 2 years post-transplant
Time frame: up to 2 years
cumulative incidence of chronic graft-versus-host disease (cGVHD)
cumulative incidence of chronic graft-versus-host disease (cGVHD) at 2 years post-transplant
Time frame: up to 2 years
Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) reactivation
the incidence of CMV and EBV reactivation within 1 year
Time frame: up to 1 year
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