Recruiting
Phase 1
Phase 2

Glofitamab & Chemoimmunotherapy

Sponsor:

Hoffmann-La Roche

Code:

NCT05533775

Conditions

Mature B-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Interventions

Obinutuzumab

Glofitamab

Rituximab

Ifosfamide

Carboplatin

Study Details

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).

Conditions

Mature B-Cell Non-Hodgkin Lymphoma

Study ID

NCT05533775

Start date

Nov 16, 2022

Status verified date

Sep, 2026

Completion date

Nov 30, 2032

Anticipated

Primary completion date

Nov 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 6 months to < 18 years at the time of signing Informed Consent for Cohort A Part 1 and Cohort B of the study, and age 6 months to < 30 years old at the time of signing Informed Consent for Cohort A Part 2 of the study
  • Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate, pleural effusion, or ascites, prior to study entry of aggressive mature B-NHL that expresses CD20 (reconfirmed by IHC or flow cytometry if IHC is not possible), including BL, BAL (mature B-cell leukemia FAB L3), DLBCL, and PMBCL, at the time of first R/R disease for Cohort A and second or greater R/R disease for Cohort B
  • Refractory or relapsed disease (i.e., prior treatment was ineffective or intolerable) following first-line standard-of-care chemoimmunotherapy for Cohort A and following at least two prior systemic chemoimmunotherapy regimens and who have exhausted all available established therapies for Cohort B
  • Measurable disease, defined as: At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension; or percentage of bone marrow involvement with lymphoma cells defined by cytomorphological analysis of bone marrow aspirates
  • Adequate performance status, as assessed according to the Lansky or Karnofsky Performance Status scales: Participants < 16 years old: Lansky Performance Status ≥ 50%; Participants ≥ 16 years old: Karnofsky Performance Status ≥ 50%
  • Adequate bone marrow, liver, and renal function
  • Negative test results for acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV)
  • Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months
  • Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment
  • Participants and/or caregivers who are willing and able to complete clinical outcome assessments throughout the study using either paper or interviewer methods

Exclusion Criteria:

  • Isolated CNS disease of mature B-NHL without systemic involvement, and primary CNS lymphoma
  • Receipt of glofitamab prior to study enrollment
  • Ongoing adverse events from prior anti-cancer therapy that were not resolved to Grade ≤ 1 (exceptions: alopecia, Grade 2 peripheral neuropathy)
  • Grade ≥ 3 adverse events, with the exception of Grade 3 endocrinopathy managed with replacement therapy
  • Participants with active infections which are not resolved prior to Day 1 of Cycle 1
  • Prior solid organ transplantation
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH), or chronic active Epstein-Barr viral infection (CAEBV)
  • Active autoimmune disease requiring treatment
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products, except if the participant was able to safely receive it after initial administration (consider consultation with Medical Monitor)
  • History of confirmed progressive multifocal leukoencephalopathy
  • Current or past history of uncontrolled non-malignant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
  • Major surgery or significant traumatic injury < 28 days prior to the obinutuzumab pretreatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
  • Administration of a live, attenuated vaccine within 4 weeks before the start of study treatment (obinutuzumab pretreatment) or at any time during the study treatment period and within 12 months after end of study treatment
  • Participants with any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug

Study Design

Enrollment

65 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

Participants will receive glofitamab + R-ICE chemoimmunotherapy for up to 3 cycles (cycle length = 21 days).

experimental: Arm B

Participants will receive glofitamab monotherapy for up to 12 cycles (cycle length = 21 days).

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

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: CO43810 https://forpatients.roche.com/ No attachments to email below.

888-662-6728global-roche-genentech-trials@gene.com

Locations

Children's Hospital of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

UCSF Benioff Children's Hospital Oakland

Recruiting

Oakland, California, United States, 94609

Kaiser Permanente Oakland Medical Center

Recruiting

Oakland, California, United States, 94611

Kaiser Permanente - Roseville

Recruiting

Roseville, California, United States, 95661

Kaiser Permanente - Santa Clara

Recruiting

Santa Clara, California, United States, 95051

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21231

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Childrens Mercy Hosp & Clinics

Recruiting

Kansas City, Missouri, United States, 64108

MSKCC

Recruiting

New York, New York, United States, 10065

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Relapsed
  • Refractory
  • Pediatrics
  • B-NHL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-09-03.