Mature B-Cell Non-Hodgkin LymphomaPhase 1/2iMATRIX GLONCT05533775
A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
A Phase 1/2 study testing Obinutuzumab, Glofitamab and Rituximab in people with Mature B-Cell Non-Hodgkin Lymphoma, run by Hoffmann-La Roche at 30 sites in 13 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 months to 30 years
- Conditions the study is for
- Mature B-Cell Non-Hodgkin Lymphoma
- What is being tested?
- Obinutuzumab, Glofitamab and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 30 sitesin 13 countries
- Study dates
- 16 Nov 2022to 30 Nov 2032
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
30 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: CO43810 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
30 sites in 13 countries
United States10 sites, 10 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21231
- Recruiting
Children's Hospital of Alabama
Birmingham, Alabama, 35233
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
- Recruiting
Childrens Mercy Hosp & Clinics
Kansas City, Missouri, 64108
- Recruiting
MSKCC
New York, New York, 10065
- Recruiting
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
- Recruiting
Kaiser Permanente Oakland Medical Center
Oakland, California, 94611
- Recruiting
Kaiser Permanente - Roseville
Roseville, California, 95661
- Recruiting
Kaiser Permanente - Santa Clara
Santa Clara, California, 95051
China3 sites, 3 recruiting
- Recruiting
West China Second University Hospital
Chengdu, 610041
- Recruiting
Sun Yet-sen University Cancer Center
Guangzhou, 510060
- Recruiting
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530201
Australia2 sites, 2 recruiting
- Recruiting
Perth Children's Hospital
Nedlands, Western Australia, 6009
- Recruiting
Queensland Children?s Hospital
South Brisbane, Queensland, 4101
Brazil2 sites, 2 recruiting
- Recruiting
Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060
- Recruiting
Graacc-Grupo de Apoio ao adolescente e a crianca com cancer
São Paulo, São Paulo, 04023-062
France2 sites, 2 recruiting
- Recruiting
Hôpital Pellegrin
Bordeaux, 33076
- Recruiting
Gustave Roussy
Villejuif, 94800
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, Lazio, 00165
- Recruiting
Ospedaliera Ospedale Infantile Regina Margherita
Turin, Piedmont, 10126
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Hospital- Pediatric Site
Seoul, 03080
- Recruiting
Asan Medical Center
Seoul, 05505
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Infantil Universitario Niño Jesus
Madrid, 28009
Czechia1 site, 1 recruiting
- Recruiting
Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie
Prague, 150 06
Germany1 site, 1 recruiting
- Recruiting
Universitaetsklinikum Muenster
Münster, 48149
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika
Budapest, 1097
Poland1 site, 1 recruiting
- Recruiting
Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu
Wroclaw, 50-556
About this study
Official title: 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).
- Conditions
- Mature B-Cell Non-Hodgkin Lymphoma
- Being tested
- Obinutuzumab, Glofitamab, Rituximab, Ifosfamide, Carboplatin
- Keywords
- Relapsed, Refractory, Pediatrics, B-NHL
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
Participants will receive intravenous (IV) obinutuzumab pretreatment on Days 1 and 2 of Cycle 1 (Cycle length = 21 days)
GlofitamabDrug
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)
RituximabDrug
Participants will receive IV rituximab on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
IfosfamideDrug
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)
CarboplatinDrug
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)
EtoposideDrug
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)
TocilizumabDrug
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Participants will receive glofitamab + R-ICE chemoimmunotherapy for up to 3 cycles (cycle length = 21 days). Receives: Drug: Obinutuzumab; Drug: Glofitamab; Drug: Rituximab; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide; Drug: Tocilizumab |
| Arm B | Experimental | Participants will receive glofitamab monotherapy for up to 12 cycles (cycle length = 21 days). Receives: Drug: Obinutuzumab; Drug: Glofitamab; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 3 treatment cycles (cycle length = 21 days)
Percentage of participants with adverse events (AEs) (Arm A)
Measured: Approximately 3 years
Serum concentration of glofitamab in combination with R-ICE chemoimmunotherapy (Arm A)
Measured: Up to 3 treatment cycles (cycle length = 21 days)
Serum concentration of glofitamab monotherapy (Arm B)
Measured: Up to 12 treatment cycles (Arm B) (cycle length = 21 days)
Secondary outcomes (11)
Objective response rate (ORR) (Arms A and B)
Measured: Up to 3 (Arm A) or 12 (Arm B) treatment cycles (cycle length = 21 days)
Duration of complete response (DOCR) (Arm A)
Measured: 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)
Measured: 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)
Measured: 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)
Overall survival (OS) (Arms A and B)
Measured: From enrollment to the date of death from any cause (Arm A = approximately 3 years, Arm B = approximately 4 years)
Percentage of participants who proceed to HSCT after up to three cycles of treatment (Arm A)
Measured: Up to 3 treatment cycles (cycle length = 21 days)
Duration of response (DOR) (Arm B)
Measured: 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)
Measured: Approximately 3 years
Serum concentration of obinutuzumab (Arms A and B)
Measured: Up to 3 (Arm A) or 12 (Arm B) treatment cycles (cycle length = 21 days)
Serum concentration of rituximab (Arm A)
Measured: Up to 3 treatment cycles (cycle length = 21 days)
Percentage of participants with anti-drug antibodies (ADAs) (Arms A and B)
Measured: Up to 3 treatment cycles (cycle length = 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start16 Nov 2022
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mature B-Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-LaRoche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533775
- Sponsor's protocol ID
- CO43810
- Acronym
- iMATRIX GLO
- Status last verified
- Oct 2026
- First submitted
- 6 Sep 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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