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Monoclonal Antibodies

Glofitamab + Pola-R-CHP for Non-Hodgkin's Lymphoma

Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2
Previously untreated participants with CD20-positive LBCL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 65 months
Awards & highlights

Study Summary

This trial aims to compare the effectiveness and safety of a combination treatment called glofitamab with polatuzumab vedotin, rituximab, cyclophosphamide, do

Who is the study for?
This trial is for people who haven't been treated for CD20-positive large B-cell lymphoma. They should be relatively active and healthy (ECOG score 0-2), have a measurable tumor, normal heart function (LVEF ≥50%), and good blood counts. Participants must test negative for COVID-19, HIV, and ensure their tumor tissue is available for the study.Check my eligibility
What is being tested?
The trial tests if Glofitamab combined with Pola-R-CHP is more effective than just Pola-R-CHP alone in treating large B-cell lymphoma. Patients will receive these treatments to see which one works better at fighting cancer.See study design
What are the potential side effects?
Possible side effects include reactions to infusion drugs, changes in blood counts leading to increased infection risk or bleeding problems, heart issues due to doxorubicin, allergic responses, nausea from chemotherapy drugs like cyclophosphamide and prednisone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am able to care for myself and perform daily activities.
Select...
My large B-cell lymphoma is CD20-positive and I haven't been treated for it yet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 65 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 65 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS) as determined by Independent Review Facility (IRF)
Secondary outcome measures
Complete response (CR) rate
Disease-free survival (DFS)
Duration of complete response (DOCR)
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Glofitamab + Pola-R-CHPExperimental Treatment6 Interventions
Participants will receive glofitamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP).
Group II: Pola-R-CHPActive Control5 Interventions
Participants will receive Pola-R-CHP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Doxorubicin
2012
Completed Phase 3
~7940
Cyclophosphamide
1995
Completed Phase 3
~3770
Prednisone
2014
Completed Phase 4
~2370
Glofitamab
2021
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,088,756 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
887,473 Total Patients Enrolled

Frequently Asked Questions

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

At how many sites is this medical trial currently being conducted?

"Currently, there are 137 active enrollment sites for this research project. These sites are distributed across various regions including London, Edegem, and Buenos Aires among numerous other locations globally. Opting for the nearest site can help reduce travel commitments after enrollment."

Answered by AI

What specific criteria must individuals meet to be eligible for enrollment in this clinical study?

"This research project aims to enroll 1130 individuals aged 18 to 80 diagnosed with non-Hodgkin's lymphoma. Essential prerequisites for potential participants include an Eastern Cooperative Oncology Group (ECOG) performance status of either 0, 1, or 2, satisfactory hematologic capabilities, and being newly diagnosed cases with CD20-positive large B-cell lymphoma."

Answered by AI

Are individuals 18 years and older eligible to participate in this study?

"Eligible candidates for this study must be aged between 18 and 80 years. It is notable that there are a substantial number of trials available for individuals below 18 years old (310 trials) as well as those above 65 years old (1570 trials)."

Answered by AI

What are the potential risks associated with the combination of Glofitamab and Pola-R-CHP in individuals undergoing treatment?

"The safety evaluation of Glofitamab + Pola-R-CHP in this Phase 3 trial is ranked at the highest level of 3 due to available efficacy data and robust safety evidence from multiple assessments."

Answered by AI

What is the current number of individuals undergoing treatment within this medical study?

"We are seeking 1130 eligible individuals to partake in this research endeavor. Potential participants have the option to enroll at various locations like Guy's Hospital Oncology Unit in London, Navarra, and UZ Antwerpen in Edegem, Victoria."

Answered by AI

Is the recruitment phase of this clinical trial still ongoing?

"Indeed, the details on clinicaltrials.gov affirm that this investigation is actively seeking volunteers. It was initially uploaded on September 18th, 2023, and its most recent update was recorded on March 26th, 2024. The study aims to enroll a total of 1130 participants from a vast network of 137 sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma
2023. "An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06047080.
~753 spots leftby Jun 2026
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