Spots Global Cancer Trial Database for A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
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Trial Identification
Brief Title: A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
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
Study ID: NCT05533775
Conditions
Study Description
Brief 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).
Detailed Description:
Eligibility
Minimum Age: 6 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Rigshospitalet; Ny Medicin til Børn med Kræft, København Ø, , Denmark
Hôpital Pellegrin; Service d'oncologie pédiatrique, Bordeaux, , France
Gustave Roussy, Villejuif, , France
Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie, Muenster, , Germany
IRCCS Ospedale Pediatrico Bambino Gesù; Clinical trial center - Pad. Salviati 1 floor, Roma, Lazio, Italy
Ospedaliera Ospedale Infantile Regina Margherita; Oncoematologia Pediatrica-Centro Trapianti Cellule, Torino, Piemonte, Italy
Seoul National University Hospital- Pediatric Site, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Infantil Universitario Niño Jesus; Servicio de Onco-hematologia, Madrid, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-LaRoche
Role: STUDY_DIRECTOR
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