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RECRUITING
NCT05533775
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Obinutuzumab

Participants will receive intravenous (IV) obinutuzumab pretreatment on Days 1 and 2 of Cycle 1 (Cycle length = 21 days)

DRUG

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)

DRUG

Rituximab

Participants will receive IV rituximab on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)

DRUG

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)

DRUG

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)

DRUG

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)

DRUG

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