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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 weeks3 visits

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

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