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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Participants will receive intravenous (IV) obinutuzumab pretreatment on Days 1 and 2 of Cycle 1 (Cycle length = 21 days)
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)
Participants will receive IV rituximab on Days 5, 6, 7, and 8 of Cycles 2 and 3 (Cycle length = 21 days)
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)
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)
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)
Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events
Children's Hospital of Alabama
Birmingham, Alabama, United States
RECRUITINGUCSF Benioff Children's Hospital Oakland
Oakland, California, United States
RECRUITINGKaiser Permanente Oakland Medical Center
Oakland, California, United States
RECRUITINGKaiser Permanente - Roseville
Roseville, California, United States
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)
Time frame: Up to 3 treatment cycles (cycle length = 21 days)
Percentage of participants with adverse events (AEs) (Arm A)
Time frame: Approximately 3 years
Serum concentration of glofitamab in combination with R-ICE chemoimmunotherapy (Arm A)
Time frame: Up to 3 treatment cycles (cycle length = 21 days)
Serum concentration of glofitamab monotherapy (Arm B)
Time frame: Up to 12 treatment cycles (Arm B) (cycle length = 21 days)
Objective response rate (ORR) (Arms A and B)
Time frame: Up to 3 (Arm A) or 12 (Arm B) treatment cycles (cycle length = 21 days)
Duration of complete response (DOCR) (Arm A)
Time frame: From the first occurrence of a documented complete response (CR) to documented disease progression or death from any cause (whichever occurs first) (approximately 3 years)
Progression-free survival (PFS) (Arm A)
Time frame: From enrollment to the first occurrence of disease progression or death from any cause (whichever occurs first) (approximately 3 years)
Event-free survival (EFS) (Arm A)
Time frame: From enrollment to the first occurrence of disease progression, death from any cause, or start of new anti-lymphoma therapy (not including planned hematopoietic stem cell transplantation (HSCT)) (approximately 3 years)
Overall survival (OS) (Arms A and B)
Time frame: From enrollment to the date of death from any cause (Arm A = approximately 3 years, Arm B = approximately 4 years)
Percentage of participants who proceed to HSCT after up to three cycles of treatment (Arm A)
Time frame: Up to 3 treatment cycles (cycle length = 21 days)
Duration of response (DOR) (Arm B)
Time frame: From the first occurrence of a documented CR or partial response (PR) until documented disease progression or death from any cause, whichever occurs first (approximately 4 years)
Percentage of participants with AEs (arm B)
Time frame: Approximately 3 years
Serum concentration of obinutuzumab (Arms A and B)
Time frame: Up to 3 (Arm A) or 12 (Arm B) treatment cycles (cycle length = 21 days)
Serum concentration of rituximab (Arm A)
Time frame: Up to 3 treatment cycles (cycle length = 21 days)
Percentage of participants with anti-drug antibodies (ADAs) (Arms A and B)
Time frame: Up to 3 treatment cycles (cycle length = 21 days)
Reference Study ID Number: CO43810 https://forpatients.roche.com
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Kaiser Permanente - Santa Clara
Santa Clara, California, United States
RECRUITINGJohns Hopkins University
Baltimore, Maryland, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGChildrens Mercy Hosp & Clinics
Kansas City, Missouri, United States
RECRUITINGMSKCC
New York, New York, United States
RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITING...and 18 more locations