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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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504264-41-00
Acronym
CO43810
Enrollment
37
Registered
2024-03-26
Start date
2022-11-04
Completion date
Unknown
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CD20 positive B-Cell Non-Hodgkin Lymphoma (NHL)

Brief summary

Cohort A - Glofitamab Combination Therapy (glofitamab plus R-ICE chemoimmunotherapy) 1. Achievement of a complete response (CR) after up to three cycles of treatment as determined by the investigator according to the International Pediatric NHL Response Criteria for pediatric participants and Lugano Classification for young adult participants, Cohort A - Glofitamab Combination Therapy (glofitamab plus R-ICE chemoimmunotherapy) 2. Incidence, nature, frequency, severity, and timing of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0) (glofitamab plus R-ICE chemoimmunotherapy), Cohort A - Glofitamab Combination Therapy (glofitamab plus R-ICE chemoimmunotherapy) 3. Change from baseline in physical findings, vital signs, clinical laboratory test results and electrocardiogram (ECG) parameters, 4. Pharmacokinetics (PK) parameters (as appropriate) and serum concentrations of glofitamab monotherapy at specified timepoints, 5. PK parameters (as appropriate) and serum concentrations of glofitamab in combination with R-ICE chemoimmunotherapy at specified timepoints

Detailed description

1. For glofitamab plus R-ICE chemoimmunotherapy: Objective response rate (ORR), Duration of complete response (DOCR), Progression-free survival (PFS) after enrollment, Event-free survival (EFS), Overall survival (OS) and percentage of patients who proceed to HSCT after up to three cycles of treatment, 2. For glofitamab monotherapy: ORR, Duration of response (DOR) and OS, Glofitamab monotherapy 3. Incidence, nature, frequency, severity, and timing of adverse events, with severity determined according to NCI CTCAE v5.0, Glofitamab monotherapy 4. Change from baseline in physical findings, vital signs, clinical laboratory test results and ECG parameters, 5. Serum concentrations of obinutuzumab at specified timepoints, 6. Serum concentrations of rituximab at specified timepoints, 7. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs against glofitamab during the study

Interventions

DRUGMabThera 500 mg concentrate for solution for infusion
DRUGRoActemra 20 mg/mL concentrate for solution for infusion
DRUGGazyvaro 1
DRUG000 mg concentrate for solution for infusion.
DRUGETOPOSIDE
DRUGCARBOPLATIN
DRUGIFOSFAMIDE
DRUGCD20 CD3 TCB

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Cohort A - Glofitamab Combination Therapy (glofitamab plus R-ICE chemoimmunotherapy) 1. Achievement of a complete response (CR) after up to three cycles of treatment as determined by the investigator according to the International Pediatric NHL Response Criteria for pediatric participants and Lugano Classification for young adult participants, Cohort A - Glofitamab Combination Therapy (glofitamab plus R-ICE chemoimmunotherapy) 2. Incidence, nature, frequency, severity, and timing of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0) (glofitamab plus R-ICE chemoimmunotherapy), Cohort A - Glofitamab Combination Therapy (glofitamab plus R-ICE chemoimmunotherapy) 3. Change from baseline in physical findings, vital signs, clinical laboratory test results and electrocardiogram (ECG) parameters, 4. Pharmacokinetics (PK) parameters (as appropriate) and serum concentrations of glofitamab mono

Secondary

MeasureTime frame
1. For glofitamab plus R-ICE chemoimmunotherapy: Objective response rate (ORR), Duration of complete response (DOCR), Progression-free survival (PFS) after enrollment, Event-free survival (EFS), Overall survival (OS) and percentage of patients who proceed to HSCT after up to three cycles of treatment, 2. For glofitamab monotherapy: ORR, Duration of response (DOR) and OS, Glofitamab monotherapy 3. Incidence, nature, frequency, severity, and timing of adverse events, with severity determined according to NCI CTCAE v5.0, Glofitamab monotherapy 4. Change from baseline in physical findings, vital signs, clinical laboratory test results and ECG parameters, 5. Serum concentrations of obinutuzumab at specified timepoints, 6. Serum concentrations of rituximab at specified timepoints, 7. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs against glofitamab during the study

Countries

Czechia, Denmark, France, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026