T Cell Lymphoma -Stratified Therapy After Response to First-line Treatment-NR

Inclusion Criteria15

• 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.