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Monoclonal Antibodies

Treatment (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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose-limiting toxicities (DLT)

Proportion of participants who achieve a complete response (CR)

Secondary outcome measures

Duration of complete response (DOCR)

Duration of response (DOR)

Incidence of grade 3 or above adverse events (AEs)

+4 more

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

~1890

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Biospecimen Collection

2004

Completed Phase 2

~1700

Obinutuzumab

2015

Completed Phase 3

~3250

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Echocardiography

2013

Completed Phase 4

~11670

Computed Tomography

2017

Completed Phase 2

~2720

Glofitamab

2021

Completed Phase 1

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor

230 Previous Clinical Trials

2,090,699 Total Patients Enrolled

Oregon Health and Science UniversityOTHER

975 Previous Clinical Trials

7,386,185 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,116 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process currently ongoing for individuals interested in participating in this trial?

"As per clinicaltrials.gov, the current trial is not accepting new participants. Originally listed on May 1st, 2024 and last modified on April 5th, 2024. Despite this specific trial being closed for recruitment, there are approximately 1718 other trials actively seeking candidates at present."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"The primary objective of this clinical investigation, to be assessed from the beginning of cycle 2 day 1 until the conclusion of Cycle 3 (each lasting for a period of 21 days), is to determine the percentage of participants who achieve complete response (CR). Secondary endpoints encompass Objective Response Rate (ORR), delineated as CR + PR. This metric will indicate the proportion within the efficacy evaluable set that attains either complete response or partial response at any on-treatment or end-of-treatment disease evaluation. ORR, along with its corresponding 95% Confidence Interval (CI), shall be meticulously documented."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma

Stephen Spurgeon 2024. "Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06357676.

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