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Chemotherapy
Glofitamab + Chemoimmunotherapy for B-Cell Lymphoma (iMATRIX GLO Trial)
Phase 1 & 2
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first study treatment to the date of death from any cause (arm a = approximately 3 years, arm b = approximately 4 years)
Awards & highlights
iMATRIX GLO Trial Summary
This trial studies a new drug to see if it's safe and effective to treat relapsed/refractory B-NHL in children & young adults.
Who is the study for?
This trial is for young individuals, from 6 months to under 18 years old (up to ≤30 years for part of the study), with relapsed/refractory mature B-cell non-Hodgkin lymphoma. They must have had previous standard chemoimmunotherapy and show measurable disease. Good performance status and organ function are required, without active infections like HBV, HCV, or HIV.Check my eligibility
What is being tested?
The trial tests glofitamab alone and combined with R-ICE chemoimmunotherapy (rituximab, ifosfamide, carboplatin, etoposide) in children and young adults who've seen their B-cell lymphoma return or resist treatment. It aims to assess safety and effectiveness.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in various organs due to glofitamab or other drugs used; infusion-related reactions; bone marrow suppression leading to blood disorders; liver or kidney issues; fatigue; allergic responses.
iMATRIX GLO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the first study treatment to the date of death from any cause (arm a = approximately 3 years, arm b = approximately 4 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first study treatment to the date of death from any cause (arm a = approximately 3 years, arm b = approximately 4 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Achievement of a complete response (CR) as determined by the investigator according to the International Pediatric NHL Response Criteria for pediatric participants and Lugano Classification for young adult participants (Arm A)
Percentage of participants with adverse events (AEs) (Arm A)
Serum concentration of glofitamab in combination with R-ICE chemoimmunotherapy (Arm A)
+1 moreSecondary outcome measures
Duration of complete response (DOCR) (Arm A)
Duration of response (DOR) (Arm B)
Event-free survival (EFS) (Arm A)
+8 moreiMATRIX GLO Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment3 Interventions
Participants will receive glofitamab monotherapy for up to 12 cycles (cycle length = 21 days).
Group II: Arm AExperimental Treatment7 Interventions
Participants will receive glofitamab + R-ICE chemoimmunotherapy for up to 3 cycles (cycle length = 21 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
2012
Completed Phase 4
~1840
Ifosfamide
2010
Completed Phase 4
~2980
Etoposide
2010
Completed Phase 3
~2440
Carboplatin
2014
Completed Phase 3
~6670
Obinutuzumab
2015
Completed Phase 3
~3250
Glofitamab
2021
Completed Phase 1
~60
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,091,327 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-LaRoche
2,202 Previous Clinical Trials
889,971 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any ongoing infections.My condition did not improve after standard cancer treatment.I have been diagnosed with progressive multifocal leukoencephalopathy.I have not had major surgery or a significant injury in the last 4 weeks.I am between 6 months and 18 years old for part 1, and up to 30 years old for part 2.I do not have any major health issues that could affect my participation or the study results.I have received glofitamab before joining this study.I have no severe side effects, except for manageable hormone issues.I have not received a live vaccine within the last 4 weeks.I do not have uncontrolled brain disorders unrelated to cancer.I have or might have had HLH or CAEBV.My bone marrow, liver, and kidneys are functioning well.I am currently being treated for an autoimmune disease.My cancer is a type of aggressive B-cell lymphoma that tests positive for CD20.My side effects from previous cancer treatments are mild or gone.I have had a solid organ transplant.I am mostly active and can carry out daily activities.I don't have any health issues that prevent me from taking new medications.My cancer can be measured and has spread to my lymph nodes, other organs, or bone marrow.I or my caregiver can complete health assessments.My B-cell non-Hodgkin lymphoma is only in my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
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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