An interventional study of allogeneic peripheral blood stem cell transplantation in Peripheral T Cell Lymphoma, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
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.
607 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 133 are open to participants now.
This study's planned enrollment of 50 is above the median of 39 across 529 interventional studies indexed under Lymphoma, T-Cell, Peripheral.
Browse Lymphoma, T-Cell, Peripheral studies →Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 182 studies on the registry; 108 are open to participants now.
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1. Age between 18 and less than 70 years, regardless of gender 2. Peripheral T-cell lymphoma (PTCL) was diagnosed according to the 2016 WHO criteria and met any of the following criteria:
Related donors must have at least 5/10 matches for HLA-A, -B, -C, -DQB1, and - DRB1.
Unrelated donors must have at least 8/10 matches for HLA-A, -B, -C, -DQB1, and -DRB1.
4.Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2. 5.ECOG (Eastern Cooperative Oncology Group) performance status: 0-2. 6.Adequate liver, kidney, and cardiopulmonary function, meeting the following requirements:
Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (Forced Expiratory Volume in 1 second) ≥ 50%.
7.Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form.
Exclusion Criteria:
Participants will receive allogeneic peripheral blood stem cell transplantation.
Other: allogeneic peripheral blood stem cell transplantation
Patients achieved response to treatment will receive allogeneic peripheral blood stem cell transplantation.
1y 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
Plan to share: No
Started Jul 2024 (actual). Primary completion is estimated for Jul 2026, 24 months after the start.
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This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Lymphoma, T-Cell, Peripheral →
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine →