Study Details

Open

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxo

The purpose of the study is to compare the effects of glofitamab with combination of drugs. There will be two arms or groups. One group will receive glofitamab + Pola-R-CHP. The other group will receive only Pola-R-CHP. Pola-R-CHP includes: Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone

Age & Gender

18 years ~ 80 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

The study involves study drug infusions or dosing, tumor tissue sample collection (biopsy), Blood sample collection, Heart function test (ECHO/MUGA if needed), Tumor assessments (CT scan. PET/CT scan, MRI), Medical history and demographic information review, covid-19 test, questionnaires, vital signs, physical exams, ECG, Urine sample collection (for women of childbearing potential), follow-up after treatment discontinuation.

In-person visits:
5-30

Total length of participation:
1 day to 65 monthd

Looking for Specific Volunteers

Able to participate:

1You have been diagnosed with CD20-positive Large B-Cell Lymphoma
You have not received treatment for your Large B-Cell Lymphoma
You do not have COVID-19 within 7 days prior to entering the trial
You have adequate hematologic and cardiac function based on tests conducted during the screening portion
You are able to provide tumor tissue for the study -either from archival or freshly collected tissue

Not eligible if:

You have had an organ transplantation.
You are receiving systemic immunosuppressive agents.
You are pregnant or breastfeeding or your partner is planning to become pregnant
You currently have CNS (central nervous system) lymphoma or had a history of CNS lymphoma
5. You had recent major surgery within 4 weeks prior to starting study treatment

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Christopher Dittus
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Glands and Hormones

IRB Number

24-1335

ClinicalTrials.gov

NCT06047080