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.
The goal of this clinical study is to evaluate the efficacy of glofitamab combined with lenalidomide in high-risk patients with R/R MCL previously treated with a BTK Inhibitor. The main questions it aims to answer are: 1. the efficacy of glofitamab combined with lenalidomide in high-risk patients with R/R MCL by best overall response rate (BOR) at the end of induction. 2. the efficacy of glofitamab combined with lenalidomide in Chinese high-risk patients with R/R MCL, including complete response rate (CRR) at C6 and the end of induction, overall response rate at C6 and the end of induction, best response of complete response (BOCR) . 3. the safety profiles of Glofitamab combined with lenalidomide in the treatment of high-risk mantle cell lymphoma. 4. the potential biomarkers which can predict efficacy and safety of Glofitamab combined lenalidomide in Chinese adult patients with relapsed/refractory high risk mantle cell lymphoma, including circulating tumor DNA (ctDNA), total metabolic tumor volume (TMTV), etc.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Glofitamab is a human IgG1-bispecific antibody targeting CD20 expressed on the surface of B cells and CD3ɛ chain expressed on the surface of T cells.
Lenalidomide is an agent with immunomodulatory and anti-angiogenic properties which confer multiple antitumor effects.
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGto evaluate the efficacy of glofitamab combined with lenalidomide in high-risk patients with R/R MCL by best overall response rate (BOR) at the end of induction.
to evaluate the efficacy of glofitamab combined with lenalidomide in high-risk patients with R/R MCL by best overall response rate (BOR) at the end of induction, defined as the percent of patients who achieve a best complete response (CR) or partial response (PR) according to the 2014 Lugano response criteria for non-Hodgkin lymphoma at the end of induction.
Time frame: 24 months
Objective Response Rate (ORR)
ORR, defined as the proportion of patients with overall response rate at C6 and the end of induction, as determined by the investigator using 2014 Lugano Response Criteria.
Time frame: up to 24 months
complete response rate (CRR)
CRR, defined as the proportion of patients with complete response rate(CRR)at C6 and the end of induction, and a best overall response of CR at any time during the studas determined by the investigator using 2014 Lugano Response Criteria.
Time frame: Up to 24 months
Duration of Response (DoR)
DoR, defined as the time from the first occurrence of a documented objective response (PR or CR) to disease progression or death from any cause (whichever occurs first) according to the 2014 Lugano Response Criteria, as determined by the investigator.
Time frame: Up to 48 months
Duration of Complete Response (DoCR)
DoCR, defined as the time from the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first according to the 2014 Lugano Response Criteria, as determined by the investigator.
Time frame: Up to 48 months
Progression-Free Survival (PFS)
PFS, defined as the time from the first study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator using 2014 Lugano Response Criteria.
Time frame: Up to 48 months
Overall Survival (OS)
OS, defined as the time from the first study treatment to the date of death from any cause.
Time frame: Up to 48 months
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