A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With R… (NCT06084936) | Clinical Trial Compass
RecruitingPhase 3
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
United States182 participantsStarted 2023-10-22
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) 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
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 antib…
What they're measuring
1
Progression-free survival (PFS)
Timeframe: From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months)
Trial details
NCT IDNCT06084936
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-08-31
Contact for this trial
Reference Study ID Number: GO43878 https://forpatients.roche.com/