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

September 2, 2026 updated by: Hoffmann-La Roche

A Phase I/II, Open-Label, Single-Arm, Two-Part Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Glofitamab in Monotherapy and in Combination With Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma

The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric and young adult participants with relapsed and refractory (R/R) mature B-cell non-Hodgkin lymphoma (B-NHL).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

Study Locations

  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Queensland Children?s Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Perth Children's Hospital
  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil, 81520-060
        • Recruiting
        • Hospital Erasto Gaertner
    • São Paulo
      • São Paulo, São Paulo, Brazil, 04023-062
        • Recruiting
        • Graacc-Grupo de Apoio ao adolescente e a crianca com cancer
  • China
      • Chengdu, China, 610041
        • Recruiting
        • West China Second University Hospital
      • Guangzhou, China, 510060
        • Recruiting
        • Sun Yet-sen University Cancer Center
      • Nanning, China, 530201
        • Recruiting
        • Guangxi Cancer Hospital of Guangxi Medical University
  • Czechia
      • Prague, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie
  • Denmark
      • København Ø, Denmark, 2100
        • Recruiting
        • Rigshospitalet
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Hôpital Pellegrin
      • Villejuif, France, 94800
        • Recruiting
        • Gustave Roussy
  • Germany
      • Münster, Germany, 48149
        • Recruiting
        • Universitaetsklinikum Muenster
  • Hungary
      • Budapest, Hungary, 1097
        • Recruiting
        • Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00165
        • Recruiting
        • IRCCS Ospedale Pediatrico Bambino Gesu
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • Recruiting
        • Ospedaliera Ospedale Infantile Regina Margherita
  • Poland
      • Wroclaw, Poland, 50-556
        • Recruiting
        • Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu
  • South Korea
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital- Pediatric Site
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital Infantil Universitario Niño Jesús
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Children's Hospital of Alabama
    • California
      • Oakland, California, United States, 94609
        • Recruiting
        • UCSF Benioff Children's Hospital Oakland
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente Oakland Medical Center
      • Roseville, California, United States, 95661
        • Recruiting
        • Kaiser Permanente - Roseville
      • Santa Clara, California, United States, 95051
        • Recruiting
        • Kaiser Permanente - Santa Clara
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Childrens Mercy Hosp & Clinics
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • MSKCC
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 6 months to < 18 years at the time of signing Informed Consent for Cohort A Part 1 and Cohort B of the study, and age 6 months to < 30 years old at the time of signing Informed Consent for Cohort A Part 2 of the study
  • Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate, pleural effusion, or ascites, prior to study entry of aggressive mature B-NHL that expresses CD20 (reconfirmed by IHC or flow cytometry if IHC is not possible), including BL, BAL (mature B-cell leukemia FAB L3), DLBCL, and PMBCL, at the time of first R/R disease for Cohort A and second or greater R/R disease for Cohort B
  • Refractory or relapsed disease (i.e., prior treatment was ineffective or intolerable) following first-line standard-of-care chemoimmunotherapy for Cohort A and following at least two prior systemic chemoimmunotherapy regimens and who have exhausted all available established therapies for Cohort B
  • Measurable disease, defined as: At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension; or percentage of bone marrow involvement with lymphoma cells defined by cytomorphological analysis of bone marrow aspirates
  • Adequate performance status, as assessed according to the Lansky or Karnofsky Performance Status scales: Participants < 16 years old: Lansky Performance Status ≥ 50%; Participants ≥ 16 years old: Karnofsky Performance Status ≥ 50%
  • Adequate bone marrow, liver, and renal function
  • Negative test results for acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV)
  • Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months
  • Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment
  • Participants and/or caregivers who are willing and able to complete clinical outcome assessments throughout the study using either paper or interviewer methods

Exclusion Criteria:

  • Isolated CNS disease of mature B-NHL without systemic involvement, and primary CNS lymphoma
  • Receipt of glofitamab prior to study enrollment
  • Ongoing adverse events from prior anti-cancer therapy that were not resolved to Grade ≤ 1 (exceptions: alopecia, Grade 2 peripheral neuropathy)
  • Grade ≥ 3 adverse events, with the exception of Grade 3 endocrinopathy managed with replacement therapy
  • Participants with active infections which are not resolved prior to Day 1 of Cycle 1
  • Prior solid organ transplantation
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH), or chronic active Epstein-Barr viral infection (CAEBV)
  • Active autoimmune disease requiring treatment
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products, except if the participant was able to safely receive it after initial administration (consider consultation with Medical Monitor)
  • History of confirmed progressive multifocal leukoencephalopathy
  • Current or past history of uncontrolled non-malignant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
  • Major surgery or significant traumatic injury < 28 days prior to the obinutuzumab pretreatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
  • Administration of a live, attenuated vaccine within 4 weeks before the start of study treatment (obinutuzumab pretreatment) or at any time during the study treatment period and within 12 months after end of study treatment
  • Participants with any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
Participants will receive glofitamab + R-ICE chemoimmunotherapy for up to 3 cycles (cycle length = 21 days).
Drug: Obinutuzumab
Participants will receive intravenous (IV) obinutuzumab pretreatment on Days 1 and 2 of Cycle 1 (Cycle length = 21 days)
Drug: Glofitamab

Arm A: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of Cycles 2 and 3

Arm B: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of each cycle thereafter

(Cycle length = 21 days)

Drug: Rituximab
Participants will receive IV rituximab on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
Drug: Ifosfamide
Participants will receive IV ifosfamide on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
Drug: Carboplatin
Participants will receive IV carboplatin on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
Drug: Etoposide
Participants will receive IV etoposide on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
Drug: Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events
Experimental: Arm B
Participants will receive glofitamab monotherapy for up to 12 cycles (cycle length = 21 days).
Drug: Obinutuzumab
Participants will receive intravenous (IV) obinutuzumab pretreatment on Days 1 and 2 of Cycle 1 (Cycle length = 21 days)
Drug: Glofitamab

Arm A: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of Cycles 2 and 3

Arm B: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of each cycle thereafter

(Cycle length = 21 days)

Drug: Tocilizumab
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Time Frame: Up to 3 treatment cycles (cycle length = 21 days)
Up to 3 treatment cycles (cycle length = 21 days)
Serum concentration of glofitamab in combination with R-ICE chemoimmunotherapy (Arm A)
Time Frame: Up to 3 treatment cycles (cycle length = 21 days)
Up to 3 treatment cycles (cycle length = 21 days)
Serum concentration of glofitamab monotherapy (Arm B)
Time Frame: Up to 12 treatment cycles (Arm B) (cycle length = 21 days)
Up to 12 treatment cycles (Arm B) (cycle length = 21 days)
Percentage of participants with adverse events (AEs) (Arm A)
Time Frame: Approximately 3 years
Approximately 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Objective response rate (ORR) (Arms A and B)
Time Frame: Up to 3 (Arm A) or 12 (Arm B) treatment cycles (cycle length = 21 days)
Up to 3 (Arm A) or 12 (Arm B) treatment cycles (cycle length = 21 days)
Percentage of participants who proceed to HSCT after up to three cycles of treatment (Arm A)
Time Frame: Up to 3 treatment cycles (cycle length = 21 days)
Up to 3 treatment cycles (cycle length = 21 days)
Serum concentration of obinutuzumab (Arms A and B)
Time Frame: Up to 3 (Arm A) or 12 (Arm B) treatment cycles (cycle length = 21 days)
Up to 3 (Arm A) or 12 (Arm B) treatment cycles (cycle length = 21 days)
Serum concentration of rituximab (Arm A)
Time Frame: Up to 3 treatment cycles (cycle length = 21 days)
Up to 3 treatment cycles (cycle length = 21 days)
Percentage of participants with anti-drug antibodies (ADAs) (Arms A and B)
Time Frame: Up to 3 treatment cycles (cycle length = 21 days)
Up to 3 treatment cycles (cycle length = 21 days)
Duration of complete response (DOCR) (Arm A)
Time Frame: From the first occurrence of a documented complete response (CR) to documented disease progression or death from any cause (whichever occurs first) (approximately 3 years)
From the first occurrence of a documented complete response (CR) to documented disease progression or death from any cause (whichever occurs first) (approximately 3 years)
Progression-free survival (PFS) (Arm A)
Time Frame: From enrollment to the first occurrence of disease progression or death from any cause (whichever occurs first) (approximately 3 years)
From enrollment to the first occurrence of disease progression or death from any cause (whichever occurs first) (approximately 3 years)
Event-free survival (EFS) (Arm A)
Time Frame: From enrollment to the first occurrence of disease progression, death from any cause, or start of new anti-lymphoma therapy (not including planned hematopoietic stem cell transplantation (HSCT)) (approximately 3 years)
From enrollment to the first occurrence of disease progression, death from any cause, or start of new anti-lymphoma therapy (not including planned hematopoietic stem cell transplantation (HSCT)) (approximately 3 years)
Duration of response (DOR) (Arm B)
Time Frame: From the first occurrence of a documented CR or partial response (PR) until documented disease progression or death from any cause, whichever occurs first (approximately 4 years)
From the first occurrence of a documented CR or partial response (PR) until documented disease progression or death from any cause, whichever occurs first (approximately 4 years)
Percentage of participants with AEs (arm B)
Time Frame: Approximately 3 years
Approximately 3 years
Overall survival (OS) (Arms A and B)
Time Frame: From enrollment to the date of death from any cause (Arm A = approximately 3 years, Arm B = approximately 4 years)
From enrollment to the date of death from any cause (Arm A = approximately 3 years, Arm B = approximately 4 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-LaRoche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CO43810

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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