a study to evaluate glofitamab as a single agent vs. investigator's choice in participants with relapsed/refractory mantle cell lymphoma

Conditions: Lymphoma

Summary: the purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (br), or lenalidomide with rituximab (r-len) in patients with relapsed or refractory (r/r) mantle cell lymphoma (mcl).


Eligibility criteria:
inclusion criteria: * life expectancy at least 12 weeks * histologically-confirmed mcl, with documentation of either overexpression of cyclin d1 or the presence of t(11:14) * relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease * at least 1 line of prior systemic therapy including a btk inhibitor and additional systemic therapy option * confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment * at least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion, or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on ct scan * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * negative hiv test at screening * adequate hematological function exclusion criteria: * pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer * leukemic, non-nodal mcl * history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products * contraindication to obinutuzumab or rituximab, and either bendamustine or lenalidomide * prior treatment with glofitamab or other bispecific antibodies targeting both cd20 and cd3 * prior treatment with car-t cell therapy * treatment with systemic therapy or btk inhibitors, or any investigational agent for the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment * primary or secondary cns lymphoma at the time of recruitment or history of cns lymphoma * current or history of cns disease, such as stroke, epilepisy, cns vasculitis, or neurodegenerative disease * history of other malignancy that could affect compliance with the protocol or interpretation of results * significant or extensive cardiovascular disease * known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment * suspected or latent tuberculosis * positive test for hepatitis b virus (hbv) or hepatitis c virus (hcv) * known or suspected chronic active epstein-barr viral infection (ebv) * known or suspected history of hemophagocytic lymphohistiocytosis (hlh) * known history of progressive multifocal leukoencephalopathy (pml) * adverse events from prior anti-cancer therapy that have not resolved to grade 1 or better * administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study * prior solid organ transplantation or allogenic stem cell transplant * eligibility for stem cell transplantation (sct) * active autoimmune disease requiring treatment * prior treatment with systemic immunosuppressive medications within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment * corticosteroid therapy within 2 weeks prior to first dose of study treatment * recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis * clinically significant history of cirrhotic liver disease