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

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).

Trial Details

NCT ID
NCT05533775
Phase
PHASE1 / PHASE2
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
Non-Hodgkin Lymphoma Lymphoma
Interventions
  • Obinutuzumab
  • Glofitamab
  • Rituximab
  • Ifosfamide
  • Carboplatin
  • Etoposide
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Oakland, California, United States|37.80437,-122.2708
  • Oakland, California, United States|37.80437,-122.2708
  • Roseville, California, United States|38.75212,-121.28801
  • Santa Clara, California, United States|37.35411,-121.95524

Key Eligibility 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 …
  • Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate, pleural effusion, or ascites, prior to study entry of aggressive…
  • Refractory or relapsed disease (i.e., prior treatment was ineffective or intolerable) following first-line standard-of-care chemoimmunotherapy for …
  • Measurable disease, defined as: At least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or at least o…

For full eligibility, visit ClinicalTrials.gov.

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