Actively Recruiting
A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
Led by Hoffmann-La Roche · Updated on 2026-05-04
65
Participants Needed
29
Research Sites
523 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 months to under 18 years for Cohort A Part 1 and Cohort B, and 6 months to under 30 years for Cohort A Part 2
- Confirmed diagnosis of aggressive mature B-cell non-Hodgkin lymphoma expressing CD20, including BL, BAL, DLBCL, or PMBCL
- Relapsed or refractory disease after first-line standard chemoimmunotherapy for Cohort A, or after at least two prior systemic chemoimmunotherapy regimens for Cohort B
- Measurable disease with at least one nodal lesion over 1.5 cm or extranodal lesion over 1.0 cm, or bone marrow involvement by lymphoma cells
- Adequate performance status (Lansky 60; 50% if under 16 years; Karnofsky 60; 50% if 16 years or older)
- Adequate bone marrow, liver, and kidney function
- Negative test for hepatitis B and C viruses
- Negative HIV test or stable HIV infection with controlled viral load and no recent opportunistic infections
- Negative SARS-CoV-2 test within 7 days before enrollment
- Willingness and ability to complete clinical outcome assessments
You will not qualify if you...
- Isolated central nervous system disease without systemic involvement or primary CNS lymphoma
- Prior treatment with glofitamab
- Ongoing adverse events from prior cancer therapy not resolved to mild or less (except alopecia and manageable peripheral neuropathy)
- Severe adverse events except controlled endocrinopathy
- Active infections not resolved before study treatment
- Prior solid organ transplant
- History or suspicion of hemophagocytic lymphohistiocytosis or chronic active Epstein-Barr virus infection
- Active autoimmune disease requiring treatment
- Severe allergic reactions to monoclonal antibody therapy or sensitivity to murine products unless safely received previously
- History of progressive multifocal leukoencephalopathy
- Uncontrolled non-malignant CNS diseases
- Significant uncontrolled health conditions affecting study compliance
- Major surgery or serious injury within 28 days before study treatment
- Recent live attenuated vaccine within 4 weeks before or during study treatment and within 12 months after
- Other medical conditions that contraindicate investigational drug use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
3
Kaiser Permanente Oakland Medical Center
Oakland, California, United States, 94611
Actively Recruiting
4
Kaiser Permanente - Roseville
Roseville, California, United States, 95661
Actively Recruiting
5
Kaiser Permanente - Santa Clara
Santa Clara, California, United States, 95051
Actively Recruiting
6
Johns Hopkins University
Baltimore, Maryland, United States, 21231
Actively Recruiting
7
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
Childrens Mercy Hosp & Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
9
MSKCC
New York, New York, United States, 10065
Actively Recruiting
10
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
11
Queensland Children?s Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
12
Perth Children's Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
13
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil, 81520-060
Actively Recruiting
14
Graacc-Grupo de Apoio ao adolescente e a crianca com cancer
São Paulo, São Paulo, Brazil, 04023-062
Actively Recruiting
15
Sun Yet-sen University Cancer Center
Guangzhou, China, 510060
Actively Recruiting
16
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, China, 530201
Actively Recruiting
17
Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie
Prague, Czechia, 150 06
Actively Recruiting
18
Rigshospitalet
København Ø, Denmark, 2100
Actively Recruiting
19
Hôpital Pellegrin
Bordeaux, France, 33076
Actively Recruiting
20
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
21
Universitaetsklinikum Muenster
Münster, Germany, 48149
Actively Recruiting
22
Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika
Budapest, Hungary, 1097
Actively Recruiting
23
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, Lazio, Italy, 00165
Actively Recruiting
24
Ospedaliera Ospedale Infantile Regina Margherita
Turin, Piedmont, Italy, 10126
Actively Recruiting
25
Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu
Wroclaw, Poland, 50-556
Actively Recruiting
26
Seoul National University Hospital- Pediatric Site
Seoul, South Korea, 03080
Actively Recruiting
27
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
28
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
29
Hospital Infantil Universitario Niño Jesus
Madrid, Spain, 28009
Actively Recruiting
Research Team
R
Reference Study ID Number: CO43810 https://forpatients.roche.com
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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