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Monoclonal Antibodies
Glofitamab + Obinutuzumab for Non-Hodgkin's Lymphoma
Phase 2
Recruiting
Research Sponsored by Reid Merryman, MD
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 up to 10 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess the effectiveness and safety of glofitamab and obinutuzumab in treating Follicular and Marginal Zone Lymphoma patients who have not been treated before.
Who is the study for?
Adults with Follicular Lymphoma or Marginal Zone Lymphoma who haven't had systemic therapy for these conditions. They should have adequate organ function, no urgent need for chemotherapy, and agree to use effective contraception. Excluded are those with recent major surgery, uncontrolled infections, certain heart conditions, severe allergies to monoclonal antibodies, autoimmune diseases without clearance, prior transplants or immunosuppressive therapy needs.
What is being tested?
The trial is testing the effectiveness and safety of combining two immunotherapy drugs: Glofitamab and Obinutuzumab in treating patients with Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL). It's aimed at those who haven't received previous treatments for their lymphoma.
What are the potential side effects?
Potential side effects from Glofitamab and Obinutuzumab may include reactions related to the immune system such as infusion reactions (symptoms that occur during or after the drug is given), increased risk of infections due to a weakened immune system, fatigue, liver issues among others.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
End of Treatment (EOT) Complete Metabolic Response (CMR) Rate
Secondary study objectives
2-year Duration of Complete Response (DOCR)
2-year Duration of Response (DOR)
2-year Overall Survival (OS)
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Obinutuzumab + Glofitamab for Marginal Zone LymphomaExperimental Treatment2 Interventions
Participants will undergo study procedures as outlined:
* Imaging scans (CT or PET) at screening and after cycles 3, 7, and 12 of treatment.
* Bone marrow biopsy at baseline.
* Cycle 1
* Days -21, -14, -7, 0 of 36 day cycle: Predetermined dose of Obinutuzumab.
* Days 1 and 8 of 36 day cycle: Predetermined dose of Glofitamab. (First dose will be administered in the hospital.)
* Cycles 2 - 12:
o Day 1 of 21 day cycle: Predetermined dose of Glofitamab.
* Bone marrow biopsy within 2 weeks of end of treatment.
* Imaging scans (CT or PET) at 12, 18, and 24 months after treatment initiation.
* Follow up visits up to 5 years after treatment completion.
Group II: Obinutuzumab + Glofitamab for Follicular LymphomaExperimental Treatment2 Interventions
Participants will undergo study procedures as outlined:
* Imaging scans (CT or PET) at screening and after cycles 3, 7, and 12 of treatment.
* Bone marrow biopsy at baseline.
* Cycle 1
* Days -21, -14, -7, 0 of 36 day cycle: Predetermined dose of Obinutuzumab.
* Days 1 and 8 of 36 day cycle: Predetermined dose of Glofitamab. (First dose will be administered in the hospital.)
* Cycles 2 - 12:
o Day 1 of 21 day cycle: Predetermined dose of Glofitamab.
* Bone marrow biopsy within 2 weeks of end of treatment.
* Imaging scans (CT or PET) at 12, 18, and 24 months after treatment initiation.
* Follow up visits up to 5 years after treatment completion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2014
Completed Phase 3
~3470
Glofitamab
2021
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
Reid Merryman, MDLead Sponsor
2 Previous Clinical Trials
59 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,560 Previous Clinical Trials
569,384 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a solid organ or bone marrow transplant.I do not have any severe or uncontrolled medical conditions.I haven't had any live vaccines in the week before or during the study.I have HIV or hepatitis B/C.I have severe heart failure.I have or might have had HLH in the past.I have been on a specific treatment in the last 6 months.I haven't had systemic therapy for my lymphoma, but I may have had radiation or steroids.I have had cancer before.I have large neck lymph nodes that might press on my airway.My lymphoma is confirmed as FL (grade 1-3A) or MZL, without active transformation.I do not have an uncontrolled infection.I have not had major surgery or significant injury in the last 4 weeks.I am on medication to suppress my immune system for another health issue.
Research Study Groups:
This trial has the following groups:- Group 1: Obinutuzumab + Glofitamab for Marginal Zone Lymphoma
- Group 2: Obinutuzumab + Glofitamab for Follicular Lymphoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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