Study of Glofitamab, Atezolizumab, and Polatuzumab Vedotin for Adults with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma

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What is this study about?

This clinical trial is focused on studying treatments for relapsed/refractory B-cell Non-Hodgkin’s Lymphoma, a type of cancer that affects the lymphatic system and has returned or not responded to previous treatments. The study involves several medications, including Glofitamab, Atezolizumab, Polatuzumab Vedotin, and a single pretreatment dose of Obinutuzumab. Additionally, a special imaging sub-study will use a tracer called 89Zr-Df-IAB22M2C to help visualize certain immune cells in the body.

The purpose of the study is to evaluate how effective these treatments are when used together in patients with this type of lymphoma. Participants will receive the medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will also explore the best dose of Glofitamab when combined with Atezolizumab or Polatuzumab Vedotin. The study will take place over several years, with regular monitoring to assess how the body responds to the treatment and to check for any side effects.

Throughout the study, participants will undergo various tests, including imaging scans, to track the progress of the treatment. The imaging sub-study aims to see how well the tracer can show the presence of certain immune cells in the cancerous areas before and after treatment. This information will help researchers understand how the immune system interacts with the cancer and the treatment. The study is designed to gather important data that could lead to better treatment options for people with this type of lymphoma in the future.

1 initial treatment phase

The study begins with the administration of a single pretreatment dose of obinutuzumab. This is given as an intravenous infusion. The purpose of this dose is to prepare the body for subsequent treatments.

2 combination therapy phase

Following the pretreatment, the main treatment phase involves the administration of glofitamab in combination with either atezolizumab or polatuzumab vedotin. These medications are also given as intravenous infusions.

The specific combination and dosage will depend on the study group assigned. The frequency and duration of these infusions will be determined by the study protocol and monitored by the medical team.

3 imaging sub-study

Participants may undergo imaging studies using a tracer called 89Zr-Df-IAB22M2C. This tracer helps visualize the infiltration of certain immune cells in the tumor tissue.

These imaging procedures are conducted before and after treatment to assess the response of the immune system to the therapy.

4 monitoring and follow-up

Throughout the trial, regular monitoring of health status, including blood tests and imaging scans, is conducted to evaluate the effectiveness of the treatment and to identify any side effects.

The study aims to determine the best overall response rate and to monitor any adverse effects related to the treatment.

5 end of study

The study is expected to conclude by September 2026. At the end of the study, a final assessment will be conducted to evaluate the long-term effects and benefits of the treatment.

Who Can Join the Study?

Must have a type of cancer called relapsed/refractory B-cell Non-Hodgkin’s Lymphoma.
Must have an Eastern Cooperative Oncology Group performance status of 0, 1, or 2, which is a way to measure how well you can perform daily activities.
Must have a life expectancy of at least 12 weeks.
Must have adequate liver, blood, and kidney function.
Must test negative for hepatitis B infection.
Must test negative for hepatitis C and HIV (Human Immunodeficiency Virus).
If you have a positive HIV test, you can still participate if you are stable on HIV treatment for at least 4 weeks, have a CD4 count of 200/mL or more, have an undetectable viral load, and have not had certain infections related to AIDS in the last 12 months.
Both men and women can participate.
Participants from vulnerable populations are eligible.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied cannot participate.
Patients who have not experienced a return or worsening of their B-cell Non-Hodgkin’s Lymphoma cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are unable to follow the study procedures or attend required visits cannot participate.
Patients who have certain medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have received certain treatments recently that might affect the study cannot participate.
Patients who have allergies to the study medications cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Odense University Hospital	Odense	Denmark
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Rigshospitalet	Copenhagen	Denmark
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Adfufal Oruxgxrkeqr Pard Gvulhnvl Xepjy	Bergamo	Italy
Irnzrwag Cvjdpm Dsrubbrooopkvxfyj	L'hospitalet De Llobregat	Spain
Axyngz Upfoevanyz Hbrhfwwl	Aarhus	Denmark
Aapzzzn Uocck Snqeiiaeq Ljznca Dh Btixcqt	Bologna	Italy
Hkimubdo Vlpl dcssmglz	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	08.05.2018
Denmark	Not recruiting	08.05.2018
Italy	Not recruiting	08.05.2018
Spain	Not recruiting	08.05.2018

Trial locations

Glofitamab is a medication being studied for its effectiveness in treating certain types of B-cell non-Hodgkin’s lymphoma. It is used in combination with other treatments to help the immune system target and destroy cancer cells.

Atezolizumab is an immunotherapy drug that helps the body’s immune system attack cancer cells. It is being tested in combination with other medications to see if it can improve treatment outcomes for patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma.

Polatuzumab Vedotin is a type of targeted therapy that combines an antibody with a chemotherapy drug. It is designed to specifically target and kill cancer cells while minimizing damage to normal cells. This medication is being studied in combination with other treatments for its potential to improve outcomes in patients with certain types of lymphoma.

Obinutuzumab is an antibody therapy that targets specific proteins on the surface of cancer cells. It is used as a pretreatment to help enhance the effectiveness of other cancer therapies in the study.

Non-Hodgkin’s Lymphoma – This is a type of cancer that originates in the lymphatic system, which is part of the body’s immune system. It involves the abnormal growth of lymphocytes, a type of white blood cell, which can form tumors throughout the body. The disease can be classified into various subtypes, including B-cell lymphomas, which are the most common. It can progress at different rates, with some forms being aggressive and others more indolent. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary widely depending on the specific subtype and other individual factors.

Trial ID:

2023-505222-34-00

Protocol code:

NP39488

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of Glofitamab, Atezolizumab, and Polatuzumab Vedotin for Adults with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?