This study is a single-center, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of an reduced-intensity conditioning (RIC) regimen with thiotepa combined with busulfan, fludarabine, and cytarabine for allogeneic hematopoietic stem cell transplantation in the treatment of relapse and refratory peripheral T-cells lymphoma. The conditioning regimen includes thiotepa at a dose of 5mg/kg/d at d -7 (1 day), fludarabine at 30mg/m2/d from d -6 to d -2 (5 days), cytarabine at 1g/m2/d from d -6 to d -2 (5 days), and busulfan at 3.2mg/kg/d from d -4 to d -3 (2 days). Conditioning begins on day -7, and 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. FDG-PET/CT imaging will be adopted 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
The reduced intensity conditioning regimen is composed by thiotepa (5mg / kg / d-7d (1d)), fludarabine (30mg / m2 / d, -6d--2d (5d)), Ara-C (1g / m2 / d, -6d--2d (5d)), and busulfan (3.2mg / kg / d, -4d-3d (2d)).
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, relapse-free survival (GRFS)
graft-versus-host disease-free, 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 GVHD
cumulative incidence of chronic GVHD at 2 years post-transplant
Time frame: up to 2 years
CMV and EBV reactivation
the incidence of CMV and EBV reactivation within 1 year
Time frame: up to 1 year
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