A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Obinutuzumab: Participants will receive intravenous (IV) obinutuzumab pretreatment on Days 1 and 2 of Cycle 1 (Cycle length = 21 days)
Glofitamab: Arm A: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of Cycles 2 and 3 Arm B: Participants will receive IV glofitamab on Days 8 and 15 of Cycle 1, then on Day 1 of each cycle thereafter (Cycle length = 21 days)
Rituximab: Participants will receive IV rituximab on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
Ifosfamide: Participants will receive IV ifosfamide on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
Carboplatin: Participants will receive IV carboplatin on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
Etoposide: Participants will receive IV etoposide on Days 3, 4, and 5 of cycle 1 and on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
Tocilizumab: Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events
Study summary
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).
Eligibility
Primary outcome measure(s)
- Achievement of a complete response (CR) as determined by the investigator according to the International Pediatric NHL Response Criteria for pediatric participants and Lugano Classification for young adult participants (Arm A) — Up to 3 treatment cycles (cycle length = 21 days)
- Percentage of participants with adverse events (AEs) (Arm A) — Approximately 3 years
- Serum concentration of glofitamab in combination with R-ICE chemoimmunotherapy (Arm A) — Up to 3 treatment cycles (cycle length = 21 days)
- Serum concentration of glofitamab monotherapy (Arm B) — Up to 12 treatment cycles (Arm B) (cycle length = 21 days)
Trial sites (30)
| Facility | City | Region | Status |
|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | Recruiting |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | Recruiting |
| Kaiser Permanente Oakland Medical Center | Oakland | California | Recruiting |
| Kaiser Permanente - Roseville | Roseville | California | Recruiting |
| Kaiser Permanente - Santa Clara | Santa Clara | California | Recruiting |
| Johns Hopkins University | Baltimore | Maryland | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Childrens Mercy Hosp & Clinics | Kansas City | Missouri | Recruiting |
| MSKCC | New York | New York | Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | Recruiting |
| Queensland Children?s Hospital | South Brisbane | Queensland | Recruiting |
| Perth Children's Hospital | Nedlands | Western Australia | Recruiting |
| Hospital Erasto Gaertner | Curitiba | Paraná | Recruiting |
| Graacc-Grupo de Apoio ao adolescente e a crianca com cancer | São Paulo | São Paulo | Recruiting |
| West China Second University Hospital | Chengdu | China | Recruiting |
| Sun Yet-sen University Cancer Center | Guangzhou | China | Recruiting |
| Guangxi Cancer Hospital of Guangxi Medical University | Nanning | China | Recruiting |
| Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie | Prague | Czechia | Recruiting |
| Rigshospitalet | København Ø | Denmark | Recruiting |
| Hôpital Pellegrin | Bordeaux | France | Recruiting |
| Gustave Roussy | Villejuif | France | Recruiting |
| Universitaetsklinikum Muenster | Münster | Germany | Recruiting |
| Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika | Budapest | Hungary | Recruiting |
| IRCCS Ospedale Pediatrico Bambino Gesù | Rome | Lazio | Recruiting |
| Ospedaliera Ospedale Infantile Regina Margherita | Turin | Piedmont | Recruiting |
| Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu | Wroclaw | Poland | Recruiting |
| Seoul National University Hospital- Pediatric Site | Seoul | South Korea | Recruiting |
| Asan Medical Center | Seoul | South Korea | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital Infantil Universitario Niño Jesus | Madrid | Spain | Recruiting |
More Hoffmann-La Roche trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05533775 on ClinicalTrials.gov ↗ ← All trials in South Korea