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A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma

NCT04313608 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-03-25

Study results available
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Summary

This study is designed to evaluate the safety and efficacy of glofitamab or mosunetuzumab in combination with gemcitabine and oxaliplatin (Glofit-GemOx or Mosun-GemOx) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL).

Conditions

Interventions

DRUG

Glofitamab

Participants will receive intravenous (IV) glofitamab in combination with gemcitabine and oxaliplatin for up to 8 cycles, followed by up to 4 cycles of glofitamab monotherapy.

DRUG

Gemcitabine

Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.

DRUG

Oxaliplatin

Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.

DRUG

Mosunetuzumab

Participants will receive IV mosunetuzumab in combination with gemcitabine and oxaliplatin for up to 8 cycles.

DRUG

Obinutuzumab

Participants will receive a single dose of IV obinutuzumab 7 days prior to the first administration of glofitamab.

DRUG

Tocilizumab

Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-04
Primary Completion
2021-10-26
Completion
2021-10-26
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04313608 on ClinicalTrials.gov