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Monoclonal Antibodies

Glofitamab + Ibrutinib + Obinutuzumab for Mantle Cell Lymphoma

Phase 1 & 2
Waitlist Available
Led By Stephen E Spurgeon
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at date of first documented cr/pr to date of progression or death due to any cause, up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing the safety and effectiveness of combining glofitamab, ibrutinib, and obinutuzumab for treating patients with mantle cell lymphoma (MCL).

Who is the study for?
This trial is for patients with Mantle Cell Lymphoma. It's designed to test the safety and effectiveness of a combination treatment involving glofitamab, ibrutinib, and obinutuzumab. Participants should meet specific health criteria but those details are not provided here.
What is being tested?
The study examines a new therapy combining glofitamab (a bispecific monoclonal antibody), ibrutinib (a kinase inhibitor), and obinutuzumab (another monoclonal antibody) in treating MCL. The trial will assess if this combo is safe, tolerable, and effective against cancer cells.
What are the potential side effects?
Potential side effects may include immune reactions due to glofitamab binding to T-cells and B-cells, issues from blocking protein signals that multiply cancer cells by ibrutinib, or growth interference in cancer cells caused by obinutuzumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at date of first documented cr/pr to date of progression or death due to any cause, up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at date of first documented cr/pr to date of progression or death due to any cause, up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of dose-limiting toxicities (DLT)
Proportion of participants who achieve a complete response (CR)
Secondary study objectives
Duration of complete response (DOCR)
Duration of response (DOR)
Incidence of grade 3 or above adverse events (AEs)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (glofitamab, ibrutinib, obinutuzumab)Experimental Treatment9 Interventions
Patients receive ibrutinib PO QD on days 1-21 of cycles 1-17. Cycles repeat every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients receive glofitamab IV over 2-4 hours on days 8 and 15 of cycle 2 and then on day 1 of cycles 3-13. Cycles repeat every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV over 4 hours at least 7 days and 24 hours prior to first dose of glofitamab. Additionally, patients undergo echocardiography during screening, bone marrow biopsy on study, and CT scans, FDG PET/CT scans or MRI, and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 4
~2060
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Glofitamab
2021
Completed Phase 1
~60
Biospecimen Collection
2004
Completed Phase 3
~2030
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Echocardiography
2013
Completed Phase 4
~11580
Obinutuzumab
2014
Completed Phase 3
~3470
Computed Tomography
2017
Completed Phase 2
~2790

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
236 Previous Clinical Trials
2,089,545 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
1,008 Previous Clinical Trials
7,414,162 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
570,029 Total Patients Enrolled
Stephen E SpurgeonPrincipal InvestigatorOHSU Knight Cancer Institute
3 Previous Clinical Trials
75 Total Patients Enrolled
~18 spots leftby May 2027