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Clinical Trials in China / NCT05533775
Recruiting Phase 1/2

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

NCT05533775 · tracked via the Priya Life Science China tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 1/2
Started
2022-11-16
Last updated
2026-09-03

Condition(s) studied

Mature B-Cell Non-Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

ObinutuzumabGlofitamabRituximabIfosfamideCarboplatinEtoposideTocilizumab

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

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

Sex
ALL
Min age
6 Months
Max age
30 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
Children's Hospital of Alabama Birmingham Alabama Recruiting
UCSF Benioff Children's Hospital Oakland Oakland California Recruiting
Kaiser Permanente Oakland Medical Center Oakland California Recruiting
Kaiser Permanente - Roseville Roseville California Recruiting
Kaiser Permanente - Santa Clara Santa Clara California Recruiting
Johns Hopkins University Baltimore Maryland Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Childrens Mercy Hosp & Clinics Kansas City Missouri Recruiting
MSKCC New York New York Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio Recruiting
Queensland Children?s Hospital South Brisbane Queensland Recruiting
Perth Children's Hospital Nedlands Western Australia Recruiting
Hospital Erasto Gaertner Curitiba Paraná Recruiting
Graacc-Grupo de Apoio ao adolescente e a crianca com cancer São Paulo São Paulo Recruiting
West China Second University Hospital Chengdu China Recruiting
Sun Yet-sen University Cancer Center Guangzhou China Recruiting
Guangxi Cancer Hospital of Guangxi Medical University Nanning China Recruiting
Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie Prague Czechia Recruiting
Rigshospitalet København Ø Denmark Recruiting
Hôpital Pellegrin Bordeaux France Recruiting
Gustave Roussy Villejuif France Recruiting
Universitaetsklinikum Muenster Münster Germany Recruiting
Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika Budapest Hungary Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù Rome Lazio Recruiting
Ospedaliera Ospedale Infantile Regina Margherita Turin Piedmont Recruiting
Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu Wroclaw Poland Recruiting
Seoul National University Hospital- Pediatric Site Seoul South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Hospital Universitari Vall d'Hebron Barcelona Spain Recruiting
Hospital Infantil Universitario Niño Jesus Madrid Spain Recruiting

On this site

📄 Rituxan (rituximab) drug profile → 📄 Actemra (tocilizumab) drug profile →

More Hoffmann-La Roche trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05533775 on ClinicalTrials.gov ↗ ← All trials in China