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
- Budapest, MagyarországSee the site
- Phase
- 1/2. fázis
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 Magyarország
- Semmelweis UniversityBudapest, MagyarországTaking 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?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2023-504264-41-00
- Record updated
- 2026. november 4.
- 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).