Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
ConditionMantle Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years at the time of signing the informed consent form.
Have a life expectancy (in the opinion of the investigator) of at least 12 weeks.
Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky > 60%).
History of previously treated MCL meeting the following criteria: Relapsed after or failed to respond to at least one prior line of systemic therapy including anti-CD20 monoclonal antibody and alkylator-containing chemotherapy.
Disqualifiers
Pregnant, or intention of becoming pregnant during the study or within 18 months after treatment with obinutuzumab or 2 months after the last dose of glofitamab, or 3 months after treatment with tocilizumab, whichever is longer; and 1 month after the last dose of pirtobrutinib.
Participants should avoid chest-feeding until at least 1 week after discontinuing pirtobrutinib.
Participants who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor. NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2g per deciliter; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome)
Any grade 3 or higher non-hematologic toxicity, except a major bleeding event or grade >= 3 arrhythmia which are exclusion criteria
Trial design
Treatments tested in this trial
- Obinutuzumab
- Glofitamab
- Pirtobrutinib
- Tumor Imaging
- Biospecimen Collection
- ClonoSeq Assay
- Bone Marrow Biopsy
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
University of California, San Francisco
Lead sponsor
Eli Lilly and Company
Collaborator
Genentech, Inc.
Collaborator
Adaptive Biotechnologies
Collaborator
Source ClinicalTrials.gov