A Single-arm, Open-label, Multi-center Clinical Study of Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With a BTK Inhibitor
A single-arm, open-label, multi-center clinical study of glofitamab combined with lenalidomide in high risk patients with relapsed or refractory Mantle Cell Lymphoma previously treated with a BTK Inhibitor. Patients will be eligible if they have received one or more prior lines of therapy, one of which must have been a BTKi. Patients will be enrolled according to a Simon two-stage design, with early stop criteria for lack of efficacy. Glofitamab will be administered intravenously and lenalidomide will be self-administered orally. Obinutuzumab pretreatment will be administered intravenously as 2 doses of 1000 mg prior to glofitamab initiation. The primary endpoint is BOR at the end of induction, evaluated by PET/CT according to Lugano criteria during study enrolment. The primary objective is to evaluate the best objective response rate (BOR) at the end of induction of the combination of glofitamab and lenalidomide.
• • Signed Informed Consent Forms
‣ Age: \>= 18 to 80 years
⁃ Eastern Cooperative Oncology Group =\< 2
⁃ Diagnosis of MCL established by histologic assessment
⁃ Previously treated with at least one prior line of systemic therapy for mantle cell lymphoma.
⁃ Prior therapy have included a BTK inhibitor, including ibrutinib, zanubrutinib, obrutinib, acalabrutinib and various BTKi in clinical trials. BTki exposure is required, which include BTKi failure or intolerance. BTKi failure is defined as progression of disease during BTKi therapy or patients have progressed or relapsed after completing BTK inhibitor therapy
⁃ At least one high risk features as classified:
• Blastoid/pleomorphic variants ✔ Ki67 ≥50% ✔ TP53 mutation or deletion
∙ Bulky disease (defined as any lesion ≥7.5 cm on the screening computed tomography \[CT\] scan）
∙ Patients that did not achieve a CR with their first-line treatment
∙ early disease progression (POD24) ✔ patients with relapse and refractory treatment above 3 lines
⁃ Measurable lesions on cross-sectional imaging documented by diagnostic imaging(MRI, CT or PET-CT), （GTD）≥1.5 cm
⁃ Adequate liver function : Total bilirubin =\< 3 x upper limit of normal (ULN) (unless has Gilbert's disease), Aspartate aminotransferase (AST) =\< 5.0 x ULN, Alanine aminotransferase (ALT) =\< 5.0 x ULN