Summary

Eligibility
for people ages 6 months to 30 years (full criteria)
Location
at Oakland, California and other locations
Dates
study started
completion around
Principal Investigator
by Jennifer Michlitsch
Headshot of Jennifer Michlitsch
Jennifer Michlitsch

Description

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).

Official Title

A Phase I/II, Open-Label, Single-Arm, Two-Part Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Glofitamab in Monotherapy and in Combination With Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma

Keywords

Mature B-Cell Non-Hodgkin Lymphoma, Relapsed, Refractory, Pediatrics, B-NHL, Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Rituximab, Obinutuzumab, Carboplatin, Etoposide, Ifosfamide, Glofitamab, Tocilizumab

Eligibility

Locations

  • UCSF Benioff Children's Hospital Oakland accepting new patients
    Oakland California 94609 United States
  • Kaiser Permanente Oakland Medical Center accepting new patients
    Oakland California 94611 United States

Lead Scientist at UCSF

  • Jennifer Michlitsch
    Professor, Pediatrics, School of Medicine. Authored (or co-authored) 23 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT05533775
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 65 study participants
Last Updated