A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Conditions

• B-Cell Non-Hodgkins Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Obinutuzumab — DRUG
  Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.
• Glofitamab — DRUG
  Participants will receive IV glofitamab, both in combination with gemcitabine and oxaliplatin and as monotherapy, for up to 12 cycles (cycle length = 21 days).
• Gemcitabine — DRUG
  Participants will receive IV gemcitabine in combination with glofitamab and oxaliplatin for up to 8 cycles (cycles length = 21 days).
• Oxaliplatin — DRUG
  Participants will receive IV oxaliplatin in combination with glofitamab and gemcitabine for up to 8 cycles (cycle length = 21 days).

Study Details

This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.

Key Dates

Start date

Mar 5, 2025

Status verified

May 2026

Primary completion

Jan 31, 2027

Completion

Mar 30, 2029

Study Design

Enrollment

100 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: R/R Aggressive B-Cell Non-Hodgkin's Lymphoma
  Participants with R/R aggressive B-cell Non-Hodgkin's Lymphoma will receive obinutuzumab pre-treatment, followed by glofitamab + gemcitabine + oxaliplatin, followed by glofitamab monotherapy.

Primary Outcome Measure

Incidence of cytokine release syndrome (CRS) [ Time Frame: Up to approximately 5 years ]

Central Contacts

• Reference Study ID Number: GO45434 https://forpatients.roche.com/
  888-662-6728
  [email protected]

Locations (33)

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