2023-504264-41-00RecruitingPhase 1/2
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
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Nov 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- First submitted
- 28 Feb 2024
- Start date
- 4 Nov 2022
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Childhood cancers, Hodgkin lymphoma
- EU CT number
- 2023-504264-41-00
- EudraCT number
- 2021-006326-48
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 37
- 11 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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).
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fakultni nemocnice v Motole | Prague | Czechia | Recruiting |
| Universitaet Muenster | Muenster | Germany | Recruiting |
| Rigshospitalet | Copenhagen Oe | Denmark | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital Infantil Universitario Nino Jesus | Madrid | Spain | Recruiting |
| Centre hospitalier Universitaire de Bordeaux | Bordeaux | France | Recruiting |
| Institut Gustave Roussy | Villejuif | France | Recruiting |
| Semmelweis University | Budapest | Hungary | Recruiting |
| Bambino Gesu Childrens Hospital | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino | Turin | Italy | Recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.