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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first study treatment to the date of death from any cause (arm a = approximately 3 years, arm b = approximately 4 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

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 more

Secondary outcome measures

Duration of complete response (DOCR) (Arm A)

Duration of response (DOR) (Arm B)

Event-free survival (EFS) (Arm A)

+8 more

iMATRIX 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

Ifosfamide

2010

Completed Phase 4

~2980

Carboplatin

2014

Completed Phase 3

~6670

Etoposide

2010

Completed Phase 3

~2440

Tocilizumab

2012

Completed Phase 4

~1840

Obinutuzumab

2015

Completed Phase 3

~3250

Glofitamab

2021

Completed Phase 1

~60

Rituximab

1999

Completed Phase 4

~1880

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,433 Previous Clinical Trials

1,090,132 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-LaRoche

2,202 Previous Clinical Trials

888,849 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05533775 — Phase 1 & 2

Non-Hodgkin's Lymphoma Research Study Groups: Arm A, Arm B

Non-Hodgkin's Lymphoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05533775 — Phase 1 & 2

Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05533775 — Phase 1 & 2

Frequently Asked Questions

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

Is this experiment accessible to individuals over thirty years of age?

"As per the outlined enrolment conditions, participants of this trial must be between 6 months and 30 years old."

Answered by AI

Is there still capacity for participants in this clinical research?

"Affirmative. According to the information indexed on clinicaltrials.gov, this study is currently enrolling with a posted date of November 16th 2022 and an edit made April 1st 2023. 65 participants are required to be recruited from 7 separate sites."

Answered by AI

Are multiple research facilities undertaking this investigation in the city?

"Currently, 7 sites are conducting this trial. These include Seoul, Barcelona and København Ø as well as numerous other places. To maximize convenience and minimize travel requirements, it's best to enroll at the location nearest you."

Answered by AI

How many test subjects are participating in this research endeavor?

"Affirmative. Per the information on clinicaltrials.gov, this experiment is accepting individuals into its program. Initially posted on 11th November 2022 and recently updated on 1st April 2023, the trial seeks to recruit 65 patients from 7 distinct locations."

Answered by AI

Is it possible for me to become involved in this clinical experiment?

"This medical study is enrolling 65 people between 6 months and 30 years of age with non-Hodgkin's lymphoma. Essential criteria for inclusion in the trial include: being aged 6 months to less than 18 when signing informed consent (for Part 1/Cohort B) or up to 30 years old at the time of signing Informed Consent for Part 2, having their histologically confirmed diagnosis prior to enrolment, showing refractory/relapsed symptoms following first line standard chemoimmunotherapy (for Cohort A) or two+ prior systemic chemoimmunotherapy regimens (for Cohort B),"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma

2022. "A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05533775.