Phase
Condition
Lymphoma, B-cell
Lymphoma
Treatment
Rituximab
Carboplatin
Ifosfamide
Clinical Study ID
Ages 6-30 All Genders
Study Summary
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
Connect with a study center
Queensland Children?s Hospital
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
Perth Children's Hospital
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Hospital Erasto Gaertner
Curitiba, Paraná 81520-060
BrazilActive - Recruiting
Graacc-Grupo de Apoio ao adolescente e a crianca com cancer
Sao Paulo, São Paulo 04023-062
BrazilActive - Recruiting
GRAACC - Grupo de Apoio ao Adolescente e a Crianca com Cancer
Sao Paulo,
BrazilActive - Recruiting
Rigshospitalet
København Ø, 2100
DenmarkActive - Recruiting
Rigshospitalet; Ny Medicin til Børn med Kræft
København Ø, 2100
DenmarkActive - Recruiting
Hôpital Pellegrin
Bordeaux, 33076
FranceActive - Recruiting
Hôpital Pellegrin; Service d'oncologie pédiatrique
Bordeaux, 33076
FranceActive - Recruiting
Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Gustave Roussy
Villejuif CEDEX, 94800
FranceActive - Recruiting
Universitaetsklinikum Muenster
Muenster, 48149
GermanyActive - Recruiting
Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie
Muenster, 48149
GermanyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù
Roma, Lazio 00165
ItalyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù; Clinical trial center - Pad. Salviati 1 floor
Roma, Lazio 00165
ItalyActive - Recruiting
Ospedaliera Ospedale Infantile Regina Margherita
Torino, Piemonte 10126
ItalyActive - Recruiting
Ospedaliera Ospedale Infantile Regina Margherita; Oncoematologia Pediatrica-Centro Trapianti Cellule
Torino, Piemonte 10126
ItalyActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Seoul National University Hospital- Pediatric Site
Seoul, 03080
Korea, Republic ofActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Infantil Universitario Niño Jesus
Madrid, 28009
SpainActive - Recruiting
Hospital Infantil Universitario Niño Jesus; Servicio de Onco-hematologia
Madrid, 28009
SpainActive - Recruiting
Children's Hospital of Alabama
Birmingham, Alabama 35233
United StatesActive - Recruiting
Kaiser Permanente Oakland Medical Center
Oakland, California 94611
United StatesActive - Recruiting
UCSF Benioff Children's Hospital Oakland
Oakland, California 94609
United StatesActive - Recruiting
Kaiser Permanente - Roseville
Roseville, California 95661
United StatesActive - Recruiting
Kaiser Permanente - Santa Clara
Santa Clara, California 95051
United StatesActive - Recruiting
Johns Hopkins University
Baltimore, Maryland 21231
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Childrens Mercy Hosp & Clinics
Kansas City, Missouri 64108
United StatesActive - Recruiting
MSKCC
New York, New York 10065
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.