Phase 2Recruiting
Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
A Multicenter Phase 2 Study of Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
- Sponsor
- University of California, San Francisco (Academic or other)
- Enrolment
- 30 planned
- Conditions
- Mantle Cell Lymphoma
- Interventions
- Obinutuzumab; Glofitamab; Pirtobrutinib; Tumor Imaging; Biospecimen Collection; ClonoSeq Assay; Bone Marrow Biopsy
- Ages
- adults, older adults
- Registry
- NCT06252675
Full record on ClinicalTrials.gov
From the registry
This phase II trial tests the safety and effectiveness of glofitamab given in combination with pirtobrutinib in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Obinutuzumab may also reduce the risk of immune-related conditions from treatment. Pirtobrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the protein that signals cancer cells to multiply. Giving glofitamab in combination with pirtobrutinib may be safe, tolerable and/or effective in treating patients with relapsed or refractory mantle cell lymphoma.
Primary outcomes
- Percentage of participants with high grade, treatment-emergent adverse events (AEs)
- Proportion of participants with Complete Response (CR)
- Proportion of participants with reported Cytokine-release syndrome (CRS)
- Proportion of participants with immune effector cell-associated neurotoxicity syndrome (ICANS)
History
Primary completion expected
Last registry update
Started
Registered