ClinicaliQ Trial Snapshot
- A Study to Evaluate Glofitamab as a Single Agent vs. Investigator’s Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma — Recruiting • Phase III • Oncology • NCT06084936.
- What is being tested: Glofitamab monotherapy (a CD20/CD3 bispecific antibody) is being compared against standard salvage regimens (rituximab-bendamustine or rituximab-lenalidomide) in patients with relapsed or refractory mantle cell lymphoma.
- Patient eligibility overview: The trial includes adult patients with mantle cell lymphoma that has progressed despite or recurred after prior treatment, representing a patient population with limited therapeutic options and poor prognosis.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * Life expectancy at least 12 weeks * Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.