Evaluate Optimization of CRS Profile for Glofit Monotherapy and Glofit+GemOx in R/R Aggressive B-NHL

Conditions

• Relapsed or Refractory Aggressive 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) followed by glofitamab monotherapy treatment regimen (Cohort A), and for glofitamab monotherapy (Cohort B) 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

First listed

Feb 3, 2025

Start date

Mar 5, 2025

Status verified

Sep 2026

Primary completion

Jan 31, 2027

Completion

Mar 30, 2029

Study Design

Enrollment

130 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A: Glofit-GemOx Combination therapy
  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.
• Experimental: Cohort B: Glofitamab Monotherapy
  Participants with R/R aggressive B-cell Non-Hodgkin's Lymphoma will receive obinutuzumab pre-treatment, 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/ No attachments to email below.
  888-662-6728 (U.S. Only)
  [email protected]
• Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (33)

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