Study on the Safety and Effectiveness of Glofitamab and Obinutuzumab for Patients with Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

2 1 1 1

What is this study about?

This clinical trial is focused on studying a type of cancer called relapsed/refractory B-cell non-Hodgkin’s lymphoma. This is a condition where a type of white blood cell, known as B-cells, becomes cancerous and either returns after treatment or does not respond to treatment. The study is testing a new treatment approach using two medications: Glofitamab and Obinutuzumab. Glofitamab is a special type of protein designed to help the immune system target and destroy cancer cells. Obinutuzumab is another protein that helps the immune system attack cancer cells and is given as a pre-treatment to prepare the body for Glofitamab.

The purpose of the study is to find the best dose of Glofitamab when used alone and in combination with Obinutuzumab, and to understand how safe and effective these treatments are for patients with this type of lymphoma. Participants in the study will receive these medications through an infusion, which means the medicine is given directly into the bloodstream through a vein. The study will monitor how the body responds to the treatment, including any side effects and how well the cancer responds.

Throughout the study, doctors will carefully observe the participants to ensure their safety and to gather information on how the treatment affects the cancer. The study aims to provide valuable insights into the potential benefits and risks of using Glofitamab and Obinutuzumab for treating relapsed/refractory B-cell non-Hodgkin’s lymphoma, which could lead to new treatment options for patients in the future.

1 initial treatment

Receive a single dose of obinutuzumab (Gazyvaro) through an intravenous infusion. This is a pre-treatment step to prepare for the main medication.

This step is crucial for preparing the body to respond to the subsequent treatments.

2 glofitamab administration

Begin receiving glofitamab through intravenous infusion. The dosage will be gradually increased to determine the most effective and safe dose.

The frequency and duration of this treatment will be determined based on individual response and tolerance.

3 combination treatment

Receive a combination of glofitamab and obinutuzumab through intravenous infusion. This combination aims to enhance the treatment’s effectiveness.

The schedule for this combination treatment will be adjusted according to the response to the initial glofitamab treatment.

4 monitoring and evaluation

Undergo regular monitoring to assess the treatment’s safety and effectiveness. This includes checking vital signs, blood tests, and other necessary evaluations.

The goal is to ensure the treatment is working as intended and to manage any side effects that may occur.

5 follow-up assessments

Participate in follow-up assessments to evaluate the long-term effects of the treatment. This includes measuring the response to treatment and overall health status.

These assessments help in understanding the treatment’s impact over time and guide any further medical decisions.

Who Can Join the Study?

  • The patient must be willing and able to follow the study’s requirements, including hospital stays and other procedures.
  • The patient must have a type of lymphoma that has come back or not responded to treatment. This includes several types like Follicular Lymphoma (FL), Marginal Zone Lymphoma, Mantle Cell Lymphoma, Diffuse Large B-cell Lymphoma (DLBCL), and others.
  • The patient must have tried at least two different treatments before, including one with a drug called anthracycline and one with a therapy targeting CD20.
  • The patient must have a life expectancy of at least 12 weeks, as judged by the doctor.
  • The patient must have a measurable disease, meaning there is a tumor that can be measured in size.
  • The patient must have a good performance status, which means they are fully active or can carry out light work.
  • The patient must have proper liver, blood, and kidney function.
  • The study is open to both male and female patients.
  • The study includes patients who may be considered vulnerable.

Who Cannot Join the Study?

  • Patients who have not experienced a return or worsening of their B-cell non-Hodgkin’s lymphoma after treatment.
  • Patients who are not able to tolerate the medications being tested in the study.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are not within the age range specified for the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the medications being tested.
  • Patients who have certain infections that could affect the study results.
  • Patients who have had a recent major surgery.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Centre Hospitalier Universitaire De Rennes Rennes France
Rigshospitalet Copenhagen Denmark
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Clurrlewj Ueyybghrhroalp Siwzunhxp Woluwe-Saint-Lambert Belgium
Hanchukf Ujvurpzdcnydc Mhpljbt Di Vmxqdtfrtd Santander Spain
Iohwoskq Czneni Duskmnypgfwnzzmgz L'hospitalet De Llobregat Spain
Hwqtjpgk Uzclkxzgfw Cjxbbvq Hcnqdxxt Helsinki Finland
Uyxrzddsjkyine Cthcdvo Kiywcheym Gdansk Poland
Hrrouhst Unbfgkqnmbxgn Hmmetszp Tzbrq y Psnhxe Ihyuiqpt Ckkmqt dzugzxdaqtjorseor (dxje Badalona Spain
Hyoinkud Vpqz dzsjyvqd Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
21.02.2017
Czechia Czechia
Not recruiting
21.02.2017
Denmark Denmark
Not recruiting
21.02.2017
Finland Finland
Not recruiting
21.02.2017
France France
Not recruiting
21.02.2017
Italy Italy
Not recruiting
21.02.2017
Poland Poland
Not recruiting
21.02.2017
Spain Spain
Not recruiting
21.02.2017

Trial locations

Glofitamab is a medication being studied for its potential to treat certain types of B-cell non-Hodgkin’s lymphoma, which is a type of cancer that affects the lymphatic system. In this trial, researchers are looking at how safe and effective glofitamab is when used alone or in combination with another medication. They are also trying to find the best dose to use. Glofitamab works by targeting specific proteins on the surface of cancer cells, which may help the immune system to attack and destroy these cells.

Obinutuzumab is another medication used in this trial. It is given to patients before they receive glofitamab. Obinutuzumab is an antibody that targets a protein found on the surface of certain cancer cells. By binding to this protein, obinutuzumab can help the immune system recognize and kill the cancer cells. In this study, obinutuzumab is used to prepare the body for treatment with glofitamab, potentially enhancing the overall effectiveness of the therapy.

Relapsed/Refractory B-cell Non-Hodgkin’s Lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting B-cells, which are a type of white blood cell. The term “relapsed” refers to the return of the disease after treatment, while “refractory” indicates that the disease does not respond to treatment. Non-Hodgkin’s lymphoma encompasses a diverse group of blood cancers that vary significantly in their behavior and treatment response. The disease can progress by spreading to other parts of the lymphatic system or organs. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression and symptoms can vary widely depending on the specific subtype of B-cell non-Hodgkin’s lymphoma.

Trial ID:
2023-505625-14-00
Protocol code:
NP30179
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

Other Trials to Consider

  • Study of drug combination therapy in children and adolescents with relapsed or refractory B-cell non-Hodgkin lymphoma using odronextamab, loncastuximab tesirine and rituximab

    Recruiting

    4 1 1 1
    Austria Belgium France The Netherlands Spain Sweden
  • Study of valemetostat tosylate tablets in patients with relapsed or refractory B-cell lymphoma, including aggressive B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and Hodgkin lymphoma

    Recruiting

    2 1 1
    Belgium France