Roche_GO41944_DLBCL (B-Cell Lymphoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental combination of drugs (glofitamab + gemcitabine and oxaliplatin) is a safe and effective treatment for DLBCL. We will compare this study drug combination to a standard, approved treatment for DLBCL (rituximab + gemcitabine and oxaliplatin).

What is the Condition Being Studied?

Diffuse Large B-Cell Lymphoma (DLBCL)

Who Can Participate in the Study?

Adults diagnosed with DLBCL who:
- Have relapsed from previous treatment; OR
- Do not have an adequate response to standard treatments

For more information about who can join this study, please contact the study team 919-681-6580.

Age Group
Adults

What is Involved?

This study has three parts: the screening period, the study drug period, and the follow-up period.

We will find out during the screening period if you are eligible to enter the study drug period. During the screening period, you will:
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws
- Have PET/CT scans

If you are eligible for the study drug period, you will:
- Be randomly assigned (like drawing numbers from a hat) to 1 of 2 groups
-- Glofit-GemOx: glofitamab in combination with gemcitabine and oxaliplatin; OR
-- R-GemOx: rituximab in combination with gemcitabine and oxaliplatin

In either group, you will receive the study drugs through infusions (IV) for up to 12 treatment cycles. Each treatment cycle lasts for 21 days. Neither you nor your doctor will be able to choose your assigned group. Your odds of being assigned to the Glofit-GemOx group are 2 out of 3, and your odds of being assigned to the R-GemOx group are 1 out of 3.

You will begin the follow-up period after the study drug period ends. During the follow-up period, you will:
- Have blood draws
- Have PET/CT scans

The follow-up period will last up to 2 years.

Study Details

Full Title
A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF GLOFITAMAB IN COMBINATION WITH GEMCITABINE PLUS OXALIPLATIN VERSUS RITUXIMAB IN COMBINATION WITH GEMCITABINE AND OXALIPLATIN IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE BCELL LYMPHOMA
Principal Investigator
Cellular Therapy Specialist
Protocol Number
IRB: PRO00106542
NCT: NCT04408638
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698