OncoMatch/Clinical Trials/NCT07460362
Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma
Is NCT07460362 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Glofitamab and Lenalidomide for mcl.
Treatment: Glofitamab · Lenalidomide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: TP53 mutation
TP53 mutation or deletion
Allowed: TP53 deletion
TP53 mutation or deletion
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BTK inhibitor (ibrutinib, zanubrutinib, obrutinib, acalabrutinib)
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
Cannot have received: immunomodulatory agent (lenalidomide)
Previous treatment with lenalidomide
Lab requirements
Liver function
Total bilirubin <= 3 x ULN (unless has Gilbert's disease), AST <= 5.0 x ULN, ALT <= 5.0 x ULN
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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