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Monoclonal Antibodies

Treatment (obinutuzumab, glofitamab, pirtobrutinib) for Mantle Cell Lymphoma

Phase 2

Waitlist Available

Led By C. Babis Andreadis, MD

Research Sponsored by C. Babis Andreadis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of previously treated MCL meeting specific criteria

Agreement for contraceptive measures for men

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

"This trial is testing the safety and effectiveness of a combination of glofitamab and pirtobrutinib in treating patients with mantle cell lymphoma that has come back or has not responded to

Who is the study for?

This trial is for individuals with mantle cell lymphoma that has returned or hasn't responded to treatment. Participants should have tried at least one prior therapy and be suitable for bone marrow biopsy, tumor imaging, and biospecimen collection.Check my eligibility

What is being tested?

The trial tests the combination of glofitamab (a monoclonal antibody) with pirtobrutinib (a kinase inhibitor) against mantle cell lymphoma. It also uses obinutuzumab potentially to reduce immune-related side effects.See study design

What are the potential side effects?

Possible side effects include reactions where the drug enters the body, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, and potential interference with organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated for mantle cell lymphoma before.

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I agree to use birth control methods.

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My side effects from previous cancer treatments have mostly gone away.

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I am 18 years old or older.

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I can do most activities by myself without help.

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I had hepatitis C but have been successfully treated and cured.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Percentage of participants with high grade, treatment-emergent adverse events (AEs)

Proportion of participants with Complete Response (CR)

Secondary outcome measures

Duration of response (DOR)

Median Overall Survival (OS)

Median Progression-free survival (PFS)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (obinutuzumab, glofitamab, pirtobrutinib)Experimental Treatment7 Interventions

Participants receive obinutuzumab IV on days 1 and 2 of cycle 1 for a total of 2 doses. Participants receive glofitamab IV on days 8 and 15 of cycle 1 and day 1 of remaining cycles. Cycles repeat every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Participants receive pirtobrutinib PO once a day (QD) on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Participants also undergo FDG-PET/CT at screening, after every 4 cycles through cycle 13 and then after every 6 cycles. Participants will undergo a bone marrow biopsy and aspiration at cycle 13 and blood sample collection throughout study and a tissue biopsy at relapse or progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pirtobrutinib

2020

Completed Phase 1

~240

Obinutuzumab

2015

Completed Phase 3

~3250

Glofitamab

2021

Completed Phase 1

~60

Biospecimen Collection

2004

Completed Phase 2

~1700

Bone Marrow Biopsy

2021

Completed Phase 2

~10

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,093 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,621 Previous Clinical Trials

3,216,572 Total Patients Enrolled

C. Babis AndreadisLead Sponsor

3 Previous Clinical Trials

72 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 of participants still ongoing for this clinical trial?

"As per clinicaltrials.gov, this investigation is not actively pursuing participants. The trial was initially shared on March 1st, 2024 and its latest update was on February 8th, 2024. While this specific study is not recruiting currently, there are a noteworthy total of 1674 other trials presently seeking eligible candidates for participation."

Answered by AI

Has the FDA granted approval for the use of obinutuzumab, glofitamab, and pirtobrutinib as a treatment?

"As a Phase 2 trial, the safety assessment by Power for this treatment regimen (obinutuzumab, glofitamab, pirtobrutinib) stands at a level of 2. This suggests that while there is some existing safety data available, efficacy data is yet to be established."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

C. Babis Andreadis 2024. "Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06252675.

All > Mantle Cell Lymphoma