Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Location status: Recruiting
NCT Number: NCT06468267
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 200080, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)).
Other names: fludarabine, busulfan, Cytarabine
Time frame: up to 1 years for the 1y-PFS and up to 2 years for the 2y-PFS
1-year and 2-year progression-free survival (PFS) rates post-transplant
Time frame: up to 180 days
acute graft-versus-host disease (aGVHD) within 180 days post-transplant
Time frame: up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR
cumulative relapse rates (CIR) 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
overall survival (OS) at 1 year and 2 years post-transplant
Time frame: up to 2 years
graft-versus-host disease-free, relapse-free survival (GRFS) at 2 years post-transplant
Time frame: up to 2 years
non-relapse mortality (NRM) at 2 years post-transplant
Time frame: up to 2 years
cumulative incidence of chronic GVHD at 2 years post-transplant
Time frame: up to 1 year
the incidence of CMV and EBV reactivation within 1 year
Contact information is provided by the study sponsor or research team.
Xianmin Song, MD
Other
Reduced Intensity Conditioning With Thiotepa Combined With Busulfan, Fludarabine and Cytarabine in Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma.
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