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

Last updated: May 2, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma, B-cell

Lymphoma

Treatment

Rituximab

Carboplatin

Ifosfamide

Clinical Study ID

NCT05533775
CO43810
  • Ages 6-30
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 6 months to < 18 years at the time of signing Informed Consent for Part 1 andCohort B of the study, and age 6 months to ≤ 30 years old at the time of signingInformed Consent for 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 thatexpresses 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 offirst 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 orintolerable) following first-line standard-of-care chemoimmunotherapy for Cohort Aand following at least two prior systemic chemoimmunotherapy regimens and who haveexhausted all available established therapies for Cohort B

  • Measurable disease, defined as: At least one bi-dimensionally measurable nodallesion, defined as > 1.5 cm in its longest dimension, or at least one bidimensionally measurable extranodal lesion, defined as > 1.0 cm in its longestdimension; or percentage of bone marrow involvement with lymphoma cells defined bycytomorphological analysis of bone marrow aspirates

  • Adequate performance status, as assessed according to the Lansky or KarnofskyPerformance 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 Cvirus (HCV)

  • Negative HIV test at screening, with the following exception: Individuals with apositive HIV test at screening are eligible provided they are stable onanti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200/uL, have anundetectable viral load, and have not had a history of opportunistic infectionattributable 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 outcomeassessments throughout the study using either paper or interviewer methods

Exclusion

Exclusion Criteria:

  • Isolated CNS disease of mature B-NHL without systemic involvement, and primary CNSlymphoma

  • Receipt of glofitamab prior to study enrollment

  • Ongoing adverse events from prior anti-cancer therapy that were not resolved toGrade ≤ 1 (exceptions: alopecia, Grade 2 peripheral neuropathy)

  • Grade ≥ 3 adverse events, with the exception of Grade 3 endocrinopathy managed withreplacement 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 chronicactive 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 tomurine products, except if the participant was able to safely receive it afterinitial 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 affectcompliance with the protocol or interpretation of results

  • Major surgery or significant traumatic injury < 28 days prior to the obinutuzumabpretreatment infusion (excluding biopsies) or anticipation of the need for majorsurgery during study treatment

  • Administration of a live, attenuated vaccine within 4 weeks before the start ofstudy treatment (obinutuzumab pretreatment) or at any time during the studytreatment period and within 12 months after end of study treatment

  • Participants with any other diseases, metabolic dysfunction, physical examinationfinding, or clinical laboratory finding giving reasonable suspicion of a disease orcondition that would contraindicate the use of an investigational drug

Study Design

Total Participants: 65
Treatment Group(s): 7
Primary Treatment: Rituximab
Phase: 1/2
Study Start date:
November 16, 2022
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Queensland Children?s Hospital

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Perth Children's Hospital

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Hospital Erasto Gaertner

    Curitiba, Paraná 81520-060
    Brazil

    Active - Recruiting

  • Graacc-Grupo de Apoio ao adolescente e a crianca com cancer

    Sao Paulo, São Paulo 04023-062
    Brazil

    Active - Recruiting

  • GRAACC - Grupo de Apoio ao Adolescente e a Crianca com Cancer

    Sao Paulo,
    Brazil

    Active - Recruiting

  • Rigshospitalet

    København Ø, 2100
    Denmark

    Active - Recruiting

  • Rigshospitalet; Ny Medicin til Børn med Kræft

    København Ø, 2100
    Denmark

    Active - Recruiting

  • Hôpital Pellegrin

    Bordeaux, 33076
    France

    Active - Recruiting

  • Hôpital Pellegrin; Service d'oncologie pédiatrique

    Bordeaux, 33076
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Gustave Roussy

    Villejuif CEDEX, 94800
    France

    Active - Recruiting

  • Universitaetsklinikum Muenster

    Muenster, 48149
    Germany

    Active - Recruiting

  • Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie

    Muenster, 48149
    Germany

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesù

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesù; Clinical trial center - Pad. Salviati 1 floor

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • Ospedaliera Ospedale Infantile Regina Margherita

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

  • Ospedaliera Ospedale Infantile Regina Margherita; Oncoematologia Pediatrica-Centro Trapianti Cellule

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital- Pediatric Site

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Infantil Universitario Niño Jesus

    Madrid, 28009
    Spain

    Active - Recruiting

  • Hospital Infantil Universitario Niño Jesus; Servicio de Onco-hematologia

    Madrid, 28009
    Spain

    Active - Recruiting

  • Children's Hospital of Alabama

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Kaiser Permanente Oakland Medical Center

    Oakland, California 94611
    United States

    Active - Recruiting

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California 94609
    United States

    Active - Recruiting

  • Kaiser Permanente - Roseville

    Roseville, California 95661
    United States

    Active - Recruiting

  • Kaiser Permanente - Santa Clara

    Santa Clara, California 95051
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21231
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Childrens Mercy Hosp & Clinics

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

  • MSKCC

    New York, New York 10065
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

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