Study on MB-CART2019.1 for Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Not Eligible for High-Dose Chemotherapy and Stem Cell Transplantation

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What is this study about?

This clinical trial is focused on studying a type of cancer called relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL). This is a condition where the cancer has returned or has not responded to initial treatment. The trial is comparing a new treatment called MB-CART2019.1 with a standard treatment known as R-GemOx, which includes the medications rituximab, gemcitabine, and oxaliplatin. The purpose of the study is to see if the new treatment can help patients live longer without the disease getting worse.

Participants in the study will receive either the new treatment or the standard treatment. The new treatment, MB-CART2019.1, is given as an infusion, which means it is administered directly into the bloodstream through a vein. The standard treatment, R-GemOx, also involves infusions of the three medications. The study will monitor participants over a period to see how well the treatments work and to check for any side effects.

The study aims to find out if MB-CART2019.1 is more effective than the standard treatment in helping patients with R-R DLBCL who are not eligible for high-dose chemotherapy and stem cell transplantation. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to gather information on the effectiveness of the treatments.

1 joining the study

Upon joining the study, participation is confirmed for individuals with relapsed or refractory diffuse large B-cell lymphoma (R-R DLBCL).

Eligibility is based on specific criteria, including previous treatment history and measurable disease.

2 randomization

Participants are randomly assigned to one of two treatment groups: the MB-CART2019.1 group or the standard of care (SoC) therapy group.

The SoC therapy includes a combination of rituximab, gemcitabine, and oxaliplatin.

3 treatment administration

For those in the MB-CART2019.1 group, the treatment involves an intravenous infusion of the study drug.

Participants in the SoC group receive rituximab, gemcitabine, and oxaliplatin through intravenous infusion as per the standard regimen.

4 monitoring and evaluation

Regular monitoring is conducted to assess the response to treatment and any side effects.

Evaluations include imaging studies and laboratory tests to track disease progression or response.

5 follow-up

Participants are followed up to evaluate long-term outcomes such as event-free survival, progression-free survival, and overall survival.

The follow-up period extends until the estimated end date of the trial in March 2030.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of diffuse large B cell lymphoma (DLBCL) or related types, based on the World Health Organization’s classification from 2016.
  • The patient must be at least 18 years old.
  • The patient must have relapsed (the disease has returned) or refractory (the disease did not respond to treatment) disease after the first round of treatment that included a combination of drugs called chemoimmunotherapy.
  • The patient must have received a first-line treatment that included an anthracycline-based regimen (a type of chemotherapy) and rituximab (a medication that targets specific cells).
  • The patient must have a measurable disease according to specific criteria, meaning the affected areas must be of a certain size and show up on a special scan called a positron emission tomography (PET) scan.
  • The patient must have a life expectancy of more than 3 months for reasons other than the primary disease.
  • The patient must be considered unable to receive high-dose chemotherapy (HDC) followed by autologous stem cell transplantation (ASCT), based on the doctor’s assessment.
  • The patient must provide a sample of tumor tissue that was collected within the last 2 years (preferably within the last 2 months) for a central review to confirm the DLBCL diagnosis.
  • Men with partners who can become pregnant must agree to use highly effective birth control methods.
  • Women who can become pregnant must agree to use highly effective birth control methods.
  • The patient must have the mental ability and legal capacity to agree to participate in the study.
  • The patient must be able to follow all study-related procedures, take medications as instructed, and attend evaluations, according to the study doctor’s opinion.

Who Cannot Join the Study?

  • Patients who are eligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT) cannot participate. Autologous stem cell transplantation is a procedure where a patient’s own stem cells are used to replace damaged or destroyed bone marrow.
  • Patients who do not have relapsed/refractory diffuse large B cell lymphoma (R-R DLBCL) are excluded. Relapsed/refractory means the disease has returned or is not responding to treatment.
  • Patients who are not in the age range specified for the study cannot participate.
  • Patients who are not part of the clinical trial groups specified for the study are excluded.
  • Patients who are not considered part of the vulnerable population selected for the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Oncopole Claudius Regaud Toulouse France
Medical University Of Vienna Vienna Austria
Hospital Universitario De Salamanca Salamanca Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Medical University Of Graz Graz Austria
Universitaet Leipzig Leipzig Germany
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland

Other Sites

Site Name City Country Status
Institut Jules Bordet Anderlecht Belgium
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Lyon Sud Pierre Benite France
Asklepios Klinik St George Hamburg Germany
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Pohjois-Pohjanmaan hyvinvointialue Oulu Finland
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
KBC Zagreb Zagreb Croatia
University Of Debrecen Debrecen Hungary
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Hospital Clinic De Barcelona Barcelona Spain
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Hopital Beaujon Clichy France
University Hospital Ostrava Ostrava Czechia
Uykgzmcwgylijfathwxpl Kqpcmaslmshwvgraiidqfnb Bmfmwn Gmix Bochum Germany
Vdvczmjupvcwsxjb hziczulgfqnahka Turku Finland
Uzrtzizbpi Mzectdx Cedahz Hwtmfifhvbdaldjtn Hamburg Germany
Uoyreukokdlcuzywcrpwl Esayd Acz Essen Germany
Otyyxjrtiydrqm Ljxa Glqp Linz Austria
Ldvci Ucilqevfhgiz Mvvfgzw Cifwwif (efjqb Leiden The Netherlands
Uahwwvpncwfn Mrmzcgl Clqglfg Gagexskfd Groningen The Netherlands
Uqmolxbapzfmtbhniyaqk Aplbsqic Augsburg Germany
Ilzgzaxk Cwuuep Dupcccccmbgvifkkt L'hospitalet De Llobregat Spain
Uefzbrmvtz Hexbjxdq Cddwzrv Cologne Germany
Azqfexnwt Urb Amsterdam The Netherlands
Ugjbqth Uizegqcjot Hnjvkpjy Uppsala Sweden
Hujnctga Ulsnvwlwjn Cqyvzxi Hqmvtffd Helsinki Finland
Eizmpnu Uoupclxrdqyw Mnhlxih Chcbvyr Rsvcdswpt (jtldlqq Mnl Rotterdam The Netherlands
Amjiaua Obcvhkrixvy Uiqdqjqqzvzym Csavcibhsbks Digak Sytocg E Dlcdn Ssharny Dj Tbsptf Turin Italy
Ulabobrjojohgruydhulq Mmllzowp Avb Munster Germany
Cnek Dm Nbucf Vandoeuvre Les Nancy France
Kzykpxcj dzz Upjfmqbqvrbq Mqvxqqmf Ate Munich Germany
Hpksczow Vgan dslmwsmj Barcelona Spain
Imnsipzt Pvdauoemmfndvpt Cbwdps Canjda Marseille France

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
26.07.2021
Belgium Belgium
Recruiting
26.07.2021
Croatia Croatia
Recruiting
26.07.2021
Czechia Czechia
Recruiting
26.07.2021
Finland Finland
Recruiting
26.07.2021
France France
Recruiting
26.07.2021
Germany Germany
Recruiting
26.07.2021
Hungary Hungary
Recruiting
26.07.2021
Italy Italy
Recruiting
26.07.2021
Lithuania Lithuania
Not recruiting
26.07.2021
Poland Poland
Not recruiting
26.07.2021
Portugal Portugal
Not recruiting
26.07.2021
Spain Spain
Recruiting
26.07.2021
Sweden Sweden
Not recruiting
26.07.2021
The Netherlands The Netherlands
Recruiting
26.07.2021

Trial locations

MB-CART2019.1 is a type of advanced therapy that uses modified immune cells to target and destroy cancer cells. In this trial, it is being tested for its effectiveness and safety in treating patients with a specific type of lymphoma, known as relapsed or refractory diffuse large B-cell lymphoma (R-R DLBCL). This therapy is being compared to standard treatments to see if it can improve patient outcomes.

Rituximab is a medication that targets specific proteins on the surface of cancer cells, helping the immune system to destroy them. It is commonly used in combination with other drugs to treat certain types of lymphoma, including R-R DLBCL.

Gemcitabine is a chemotherapy drug that works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is often used in combination with other medications to treat various types of cancer, including lymphoma.

Oxaliplatin is another chemotherapy drug that damages the DNA of cancer cells, leading to their death. It is used in combination with other drugs to enhance the treatment of certain cancers, including lymphoma.

Relapsed/Refractory Diffuse Large B Cell Lymphoma (R-R DLBCL) – This is a type of non-Hodgkin lymphoma that affects B cells, which are a type of white blood cell. It is characterized by the return or persistence of the disease after initial treatment. The disease typically presents with rapidly growing lymph nodes, often in the neck, armpit, or groin. As it progresses, it can spread to other parts of the body, including the bone marrow, spleen, and liver. Symptoms may include fever, night sweats, and unexplained weight loss. The condition is considered rare and can be challenging to manage due to its aggressive nature.

Trial ID:
2023-506270-13-00
Protocol code:
M-2020-371
NCT ID:
NCT04844866
Trial Phase:
Therapeutic exploratory (Phase II)

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