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A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
Sponsor: Hoffmann-La Roche
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).
Official title: 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
Key Details
Gender
All
Age Range
6 Months - 30 Years
Study Type
INTERVENTIONAL
Enrollment
65
Start Date
2022-11-16
Completion Date
2032-11-30
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
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
Locations (29)
Children's Hospital of Alabama
Birmingham, Alabama, United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States
Kaiser Permanente Oakland Medical Center
Oakland, California, United States
Kaiser Permanente - Roseville
Roseville, California, United States
Kaiser Permanente - Santa Clara
Santa Clara, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Childrens Mercy Hosp & Clinics
Kansas City, Missouri, United States
MSKCC
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Queensland Children?s Hospital
South Brisbane, Queensland, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Graacc-Grupo de Apoio ao adolescente e a crianca com cancer
São Paulo, São Paulo, Brazil
Sun Yet-sen University Cancer Center
Guangzhou, China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, China
Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie
Prague, Czechia
Rigshospitalet
København Ø, Denmark
Hôpital Pellegrin
Bordeaux, France
Gustave Roussy
Villejuif, France
Universitaetsklinikum Muenster
Münster, Germany
Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika
Budapest, Hungary
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, Lazio, Italy
Ospedaliera Ospedale Infantile Regina Margherita
Turin, Piedmont, Italy
Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu
Wroclaw, Poland
Seoul National University Hospital- Pediatric Site
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Infantil Universitario Niño Jesus
Madrid, Spain