A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

November 16, 2022

Primary Completion Date

May 31, 2029

Study Completion Date

September 30, 2029

Conditions
Mature B-Cell Non-Hodgkin Lymphoma
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

Trial Locations (26)

2100

RECRUITING

Rigshospitalet, København Ø

4101

RECRUITING

Queensland Children?s Hospital, South Brisbane

6009

RECRUITING

Perth Children's Hospital, Nedlands

10065

RECRUITING

MSKCC, New York

10126

RECRUITING

Ospedaliera Ospedale Infantile Regina Margherita, Turin

21231

RECRUITING

Johns Hopkins University, Baltimore

28009

RECRUITING

Hospital Infantil Universitario Niño Jesus, Madrid

33076

RECRUITING

Hôpital Pellegrin, Bordeaux

35233

RECRUITING

Children's Hospital of Alabama, Birmingham

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

48149

RECRUITING

Universitaetsklinikum Muenster, Münster

64108

RECRUITING

Childrens Mercy Hosp & Clinics, Kansas City

94609

RECRUITING

UCSF Benioff Children's Hospital Oakland, Oakland

94611

RECRUITING

Kaiser Permanente Oakland Medical Center, Oakland

94800

RECRUITING

Gustave Roussy, Villejuif

95051

RECRUITING

Kaiser Permanente - Santa Clara, Santa Clara

95661

RECRUITING

Kaiser Permanente - Roseville, Roseville

510060

RECRUITING

Sun Yet-sen University Cancer Center, Guangzhou

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

81520-060

RECRUITING

Hospital Erasto Gaertner, Curitiba

04023-062

RECRUITING

Graacc-Grupo de Apoio ao adolescente e a crianca com cancer, São Paulo

00165

RECRUITING

IRCCS Ospedale Pediatrico Bambino Gesù, Rome

50-556

RECRUITING

Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu, Wroclaw

03080

RECRUITING

Seoul National University Hospital- Pediatric Site, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY