Study on the Safety and Effectiveness of Polatuzumab Vedotin with Rituximab, Gemcitabine, and Oxaliplatin for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL), which is a form of non-Hodgkin lymphoma. The study is specifically looking at patients whose DLBCL has returned or has not responded to previous treatments. The trial is testing a combination of medications to see if they can improve treatment outcomes for these patients. The medications being studied include Polatuzumab Vedotin, known by its code name RO5541077, and Rituximab, which are both given as infusions. These are combined with two chemotherapy drugs, Gemcitabine and Oxaliplatin, which are also administered through infusions. Some patients will receive all four medications, while others will receive only Rituximab, Gemcitabine, and Oxaliplatin, along with a placebo.

The purpose of the study is to evaluate the safety and effectiveness of the combination treatment compared to the standard treatment without Polatuzumab Vedotin. The study will monitor how well patients respond to the treatment and how long they live after receiving it. It will also look at any side effects, with a particular focus on a condition called peripheral neuropathy, which involves nerve damage that can cause weakness, numbness, and pain, usually in the hands and feet.

Participants in the study will receive their treatments through intravenous infusions, which means the medication is delivered directly into a vein. The study will take place over a period of time, with regular check-ups to monitor the patients’ health and response to the treatment. The trial aims to provide valuable information that could lead to better treatment options for patients with relapsed or refractory DLBCL.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as having relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and previous treatment history.

A performance status assessment is conducted to ensure adequate physical condition for participation.

2 treatment phase

The treatment involves two groups: one receiving Polatuzumab Vedotin in combination with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx), and the other receiving Rituximab, Gemcitabine, and Oxaliplatin (R-GemOx) alone.

All medications are administered through intravenous infusion.

The specific dosages and frequency of administration are determined by the study protocol and medical team.

3 monitoring and assessments

Regular monitoring is conducted to evaluate the safety and effectiveness of the treatment.

Assessments focus on overall survival, incidence of side effects, and specific attention to peripheral neuropathy, which is a type of nerve damage that can cause weakness, numbness, and pain.

4 completion of treatment

The treatment phase continues until the study’s end date or until the medical team decides it is appropriate to stop.

Final assessments are conducted to evaluate the outcomes and any long-term effects of the treatment.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), which is a type of cancer affecting the lymphatic system.
  • The disease must have either come back after treatment (relapsed) or not responded to treatment (refractory).
  • The patient must have received at least one previous treatment that involved medication given through the bloodstream (systemic therapy).
  • The patient must have at least one tumor that can be measured in two directions, which helps doctors track the size of the tumor.
  • The patient must have a performance status score of 0, 1, or 2 according to the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well a patient can perform daily activities.
  • The patient must have adequate hematological function, meaning their blood cell levels are within a safe range.
  • The study is open to both male and female patients.
  • The study includes patients who are considered part of a vulnerable population, meaning they may need extra protection or care.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied cannot participate.
  • Patients who have not experienced a return or worsening of their cancer after treatment cannot participate.
  • Patients who have certain other health conditions that might interfere with the study cannot participate.
  • Patients who are currently pregnant or breastfeeding cannot participate.
  • Patients who are unable to follow the study procedures or attend study visits cannot participate.
  • Patients who have had a recent major surgery or are recovering from surgery cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had an allergic reaction to any of the study drugs or similar drugs cannot participate.
  • Patients who have certain infections that are not well controlled cannot participate.
  • Patients who have a history of certain heart problems cannot participate.

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
Centre Hospitalier Universitaire De Nimes Nimes France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Azienda Ospedaliera di Padova Padua Italy
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Azienda USL Toscana Centro Prato Italy
Hospital Universitario De Canarias La Laguna Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Lfrqv Ggndvjp Hprylwyv Oi Alypgx Athens Greece
Cpcdqo Hldgzhnwfeq Rgjoghnp Uqfvpdnzyxvjp Db Tnamw Tours France
Heaxejbg Udosvoqssxlzu Hahrarsl Tfrog y Ploexa Ikqkcket Csksyg dsicbtyrsiiyiajkw (daaz Badalona Spain
Ulbrrureie Grffqwq Hqvandkl Adhvpdh Athens Greece

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
30.04.2020
Germany Germany
Not recruiting
30.04.2020
Greece Greece
Not recruiting
30.04.2020
Italy Italy
Not recruiting
30.04.2020
Spain Spain
Not recruiting
30.04.2020

Trial locations

Polatuzumab Vedotin is a medication used in this trial to treat patients with relapsed or refractory diffuse large B-cell lymphoma. It is an antibody-drug conjugate that targets cancer cells and delivers a chemotherapy agent directly to them, helping to destroy the cancer cells while minimizing damage to healthy cells.

Rituximab is a medication that is part of the treatment regimen in this trial. It is a monoclonal antibody that targets a specific protein on the surface of certain cancer cells, helping the immune system to identify and destroy these cells.

Gemcitabine is a chemotherapy drug used in this trial. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing, which helps to slow down or stop the progression of the cancer.

Oxaliplatin is another chemotherapy drug included in the treatment regimen. It works by damaging the DNA in cancer cells, which prevents them from multiplying and can lead to cell death, helping to reduce the size of tumors and control the spread of cancer.

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma that affects B-lymphocytes, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. The disease can start in any part of the body and may spread to other areas, including the bone marrow and central nervous system. Symptoms often include swollen lymph nodes, fever, night sweats, and weight loss. DLBCL is considered aggressive due to its fast progression, but it is also one of the most common and treatable forms of lymphoma.

Trial ID:
2024-512537-33-00
Protocol code:
MO40598
Trial Phase:
Therapeutic confirmatory (Phase III)

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