Allogeneic Hematopoietic Stem Cell Transplantation Versus Autologous Hematopoietic Stem Cell Transplantation for Peripheral T-cell Lymphoma Patients With Partial Remission After First-line Systemic Therapy : A Prospective, Multicenter, Cohort Study(T-START-PR)
This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the allogeneic hematopoietic stem cell transplantation group (Allo-HSCT) and the autologous hematopoietic stem cell transplantation group (Auto-HSCT). It aims to evaluate the efficacy and safety of Auto-HSCT and Allo-HSCT in the treatment of peripheral T-cell lymphoma that has achieved partial response (PR) after first-line therapy. During the screening/baseline period, informed consent will be obtained, and inclusion/exclusion criteria will be verified. Group assignment (Allo-HSCT vs. Auto-HSCT) will be determined taking into account the availability of a matched donor and the patient's preference. The study plans to enroll 44 patients in the allogeneic hematopoietic stem cell transplantation group, while all concurrent patients undergoing autologous stem cell transplantation will be included in the other group for inverse probability weighting analysis. Data on demographics and medical history will be collected, and assessments including vital signs, physical examination, PET-CT, bone marrow aspiration smear, flow cytometry, and bone marrow pathology will be performed.
• Age \& Sex:
• Males or females aged 18 to 70 years (inclusive).
• ECOG performance status score of 0 to 1, with no deterioration within the last two weeks.
• Expected survival period greater than 12 weeks.
• Patients must have a histopathological confirmation of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al. 2016). Eligible histological subtypes are limited to the following:
‣ Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)
⁃ Anaplastic large cell lymphoma, ALK-negative (ALK-ALCL)
⁃ Follicular helper T-cell lymphoma or PTCL with TFH phenotype (FTCL or PTCL-TFH)
• Patients undergoing allogeneic hematopoietic stem cell transplantation must have a suitable stem cell donor:
• (i) Related donors must be at least 5/10 matched for HLA-A, -B, -C, -DQB1, and -DRB1.
• (ii) Unrelated donors must be at least 8/10 matched for HLA-A, -B, -C, -DQB1, and -DRB1.
• Patients must have achieved a partial response (PR) as per the Lugano 2014 response criteria for lymphoma after six cycles of CHOP, BV-CHP or CHOP-like chemotherapy.
• Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≤ 2.
• Adequate hepatic, renal, cardiac, and pulmonary function, defined as follows:
∙ Hepatic function: Serum total bilirubin ≤ 2 × upper limit of normal (ULN) (≤ 3.0 × ULN in cases of Gilbert's syndrome or baseline hepatic involvement); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5.0 × ULN in cases of hepatic involvement).
‣ Renal function: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min as calculated or measured by the Cockcroft-Gault method.
‣ Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition (MUGA) scan or echocardiography (ECHO).
‣ Baseline oxygen saturation \> 92%.
‣ Pulmonary function: Diffusing capacity of the lung for carbon monoxide (DLCO) (hemoglobin-corrected) ≥ 40% and forced expiratory volume in 1 second (FEV1) ≥ 50%.