Non Hodgkin Lymphoma Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age 6 months to < 18 years at the time of signing Informed Consent for Part 1 and Cohort B of the study, and age 6 months to ≤ 30 years old at the time of signing Informed 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 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 is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

65

Study ID:

NCT05533775

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 22 Locations for this study

See Locations Near You

Children's Hospital of Alabama
Birmingham Alabama, 35233, United States
UCSF Benioff Children's Hospital Oakland
Oakland California, 94609, United States
Kaiser Permanente Oakland Medical Center
Oakland California, 94611, United States
Kaiser Permanente - Roseville
Roseville California, 95661, United States
Kaiser Permanente - Santa Clara
Santa Clara California, 95051, United States
Johns Hopkins University
Baltimore Maryland, 21205, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Childrens Mercy Hosp & Clinics
Kansas City Missouri, 64108, United States
MSKCC
New York New York, 10065, United States
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States
Queensland Children?s Hospital
South Brisbane Queensland, 4101, Australia
Perth Children's Hospital
Nedlands Western Australia, 6009, Australia
Rigshospitalet; Ny Medicin til Børn med Kræft
København Ø , 2100, Denmark
Hôpital Pellegrin; Service d'oncologie pédiatrique
Bordeaux , 33076, France
Gustave Roussy
Villejuif , 94805, France
Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie
Muenster , 48149, Germany
IRCCS Ospedale Pediatrico Bambino Gesù; Clinical trial center - Pad. Salviati 1 floor
Roma Lazio, 00165, Italy
Ospedaliera Ospedale Infantile Regina Margherita; Oncoematologia Pediatrica-Centro Trapianti Cellule
Torino Piemonte, 10126, Italy
Seoul National University Hospital- Pediatric Site
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Infantil Universitario Niño Jesus; Servicio de Onco-hematologia
Madrid , 28009, Spain

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

65

Study ID:

NCT05533775

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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