T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-NR
This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the allogeneic hematopoietic stem cell transplantation group (Allo-HSCT) and the alternative salvage regimens. It aims to evaluate the efficacy and safety of Allo-HSCT and alternative salvage regimens in the treatment of peripheral T-cell lymphoma that has achieved no response (NR) 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. alternative salvage regimens) will be determined taking into account the availability of a matched donor and the patient's preference. The study plans to enroll 29 patients in each group. 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.
• At the time of ICF signing, the subject must be 18-70 years of age, inclusive, regardless of gender.
• The subject must have achieved Stable Disease (SD) or Progressive Disease (PD) as assessed per the Lugano 2014 classification criteria after first-line systemic standard therapy (CHOP or a CHOP-like regimen). This includes subjects who failed to achieve a response after at least 4 cycles of standard chemotherapy or who experienced disease progression during treatment.
• The subject must have a histologically confirmed diagnosis of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al. 2016). Eligible histological subtypes are restricted to the following: Not Otherwise Specified (PTCL-NOS); ALK-negative Anaplastic Large Cell Lymphoma (ALK- ALCL); Follicular Helper T-cell Lymphoma or PTCL with a TFH phenotype (FTCL or PTCL-TFH). Additionally, they must meet the following condition:
• Patients scheduled for allogeneic hematopoietic stem cell transplantation must have a suitable stem cell donor:
• i. Related donors must be at least 5/10 matched at HLA-A, -B, -C, -DQB1, and -DRB1.
• ii. Unrelated donors must be at least 8/10 matched at HLA-A, -B, -C, -DQB1, and -DRB1.
• Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score ≤ 2.
• ECOG Performance Status score of 0 or 1, with no deterioration over the preceding two weeks.
• Life expectancy of at least 12 weeks.
• Adequate hepatic, renal, cardiac, and pulmonary function, defined as:
• i. Hepatic: Serum total bilirubin ≤ 2 × ULN (or ≤ 3.0 × ULN in cases of Gilbert's syndrome or documented baseline liver involvement); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (or ≤ 5.0 × ULN in cases of liver involvement).
• ii. Renal: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault formula or measured.
• iii. Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by Multigated Acquisition (MUGA) scan or Echocardiography (ECHO).
• iv. Baseline oxygen saturation on room air \> 92%. v. Pulmonary: Diffusing capacity of the lungs for carbon monoxide (DLCO), corrected for hemoglobin, ≥ 40% and Forced Expiratory Volume in 1 second (FEV1) ≥ 50% of predicted.
• Voluntary participation in the clinical study; full understanding and awareness of the study and having signed the ICF; willingness and ability to comply with and complete all trial procedures.