Tests glofitamab alone and with chemotherapy in young people with relapsed lymphoma
Tests glofitamab, alone or with chemotherapy, in children and young adults with returned B-cell lymphoma.
Plain-language title generated from the registry record
Registry title: A Study 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
Key facts
- Where
- Copenhagen Oe, DenmarkSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children (6 months to under 18 years) whose aggressive mature B-cell non-Hodgkin lymphoma with CD20 came back or did not respond to first treatment.
- Age
- 6 months to under 18 years. Young adults aged 18-30 can no longer join Part 2 (protocol version 7).
- Sex
- All sexes can join.
- Disease stage
- Aggressive mature B-cell non-Hodgkin lymphoma with CD20 (Burkitt lymphoma, Burkitt leukemia, DLBCL or PMBCL) that came back or did not respond. It must be measurable by scan or in bone marrow.
- Earlier treatment
- Cohort A: the disease came back or did not respond after first-line standard chemoimmunotherapy. Cohort B (closed to new people): at least two earlier chemoimmunotherapy regimens.
- Biomarker or test result
- Lymphoma cells must show CD20, confirmed by biopsy or flow cytometry. Tests for hepatitis B, hepatitis C, HIV and SARS-CoV-2 must be negative.
Main reasons for not taking part
- Lymphoma only in the central nervous system, or primary CNS lymphoma
- Cohort A: earlier treatment with glofitamab
- Cohort A: earlier R-ICE chemoimmunotherapy
- Cohort A: more than one earlier line of standard chemoimmunotherapy
- Cohort B: uncontrolled involvement of the central nervous system
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old is the patient who may join a trial?
- Is this cancer newly diagnosed, or has it come back or not responded to treatment?
- Does the patient have an infection that is not under control, or HIV or hepatitis B or C?
Where in Denmark
- RigshospitaletCopenhagen Oe, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2023-504264-41-00
- Record updated
- 4 November 2026
- Original description
To evaluate the efficacy of glofitamab in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) chemoimmunotherapy, as assessed by the investigator based on achievement of a complete response (CR) To evaluate the safety and tolerability of glofitamab in combination with R-ICE chemoimmunotherapy To determine the pharmacokinetics of glofitamab alone and in combination with R-ICE chemoimmunotherapyRead full original descriptionShow less
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
To evaluate the efficacy of glofitamab in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) chemoimmunotherapy, as assessed by the investigator based on achievement of a complete response (CR) To evaluate the safety and tolerability of glofitamab in combination with R-ICE chemoimmunotherapy To determine the pharmacokinetics of glofitamab alone and in combination with R-ICE chemoimmunotherapy
Inclusion: Age 6 months to <18 years at the time of signing Informed Consent Effective as of protocol version 7, eligibility for Part 2 of the study will no longer be extended to young adult participants (aged 18–30 years); Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate, pleural effusion, or ascites, prior to study entry of aggressive mature B-cell non-Hodgkin lymphoma (B-NHL) that expresses CD20 (reconfirmed by immunohistochemistry [IHC]), or flow cytometry if IHC is not possible including Burkitt lymphoma (BL), Burkitt leukemia (BAL) (mature B-cell leukemia fragment antigen-binding [FAB] L3), diffuse large B-cell lymphoma (DLBCL), and primary mediastinal large B-cell lymphoma (PMBCL), at the time of first relapsed or refractory (R/R) disease for Cohort A and second or greater R/R disease for Cohort B (Cohort B is closed to further enrollment, as of protocol version 7); 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 (Cohort B is closed to further enrollment, as of protocol version 7). 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; Adequate bone marrow, liver and renal function; Negative test results for hepatitis B and hepatitis C viruses (HBV and HCV), human immunodeficiency virus (HIV) and severe-acute-respiratory-syndrome-related coronavirus 2 (SARS-CoV-2).