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Study of Rituximab, Gemcitabine, Dexamethasone, and Platinum with or without Selinexor 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), specifically in patients whose disease has returned or has not responded to previous treatments, known as Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL). The study is investigating the effectiveness of a treatment combination that includes the drugs Rituximab, Gemcitabine, Dexamethasone, and a type of Platinum drug, with or without an additional drug called Selinexor. Selinexor is taken as a tablet by mouth.

The purpose of the study is to compare how well patients respond to the treatment with and without Selinexor. The study is divided into two phases. In the first phase, the focus is on how many patients show a positive response to the treatment. In the second phase, the study looks at how long patients live without the disease getting worse. Some patients will receive a placebo, which is a tablet that looks like the real medication but does not contain the active drug, to compare the effects of the actual treatment.

Participants in the study will receive the treatment over a period of time, and their health will be monitored to see how the disease responds. The study aims to provide more information on whether adding Selinexor to the existing treatment can improve outcomes for patients with RR DLBCL. This research could help in developing better treatment strategies for this type of lymphoma in the future.

1 initial treatment phase

The study involves two phases. In the initial phase, patients receive a combination of medications known as R-GDP, which includes rituximab, gemcitabine, dexamethasone, and a platinum-based drug. This combination is administered to treat diffuse large B-cell lymphoma that has returned or not responded to previous treatments.

In addition to R-GDP, patients may receive either selinexor or a placebo. Selinexor is taken orally in tablet form. The dosage is either 40 mg or 60 mg, depending on the specific requirements of the study phase.

2 treatment evaluation

The effectiveness of the treatment is evaluated using criteria known as the Lugano 2014 Criteria. This involves assessing the overall response rate (ORR) in the initial phase and progression-free survival (PFS) in the subsequent phase.

Patients undergo regular assessments to monitor their response to the treatment and any potential side effects.

3 continuation phase

In the continuation phase, patients who initially received selinexor continue with selinexor, while those who received a placebo continue with a placebo. This phase aims to further evaluate the progression-free survival of patients.

The treatment and monitoring continue as per the study protocol, with regular assessments to ensure patient safety and treatment efficacy.

4 study completion

The study is expected to conclude by November 2025. Upon completion, the data collected will be analyzed to determine the overall effectiveness and safety of the treatment combinations.

Patients will receive follow-up care as needed, and the results will contribute to understanding the best treatment options for relapsed or refractory diffuse large B-cell lymphoma.

Who Can Join the Study?

  • Patients must be 18 years or older.
  • Patients should have an estimated life expectancy of more than 3 months at the time of screening.
  • Patients with primary refractory DLBCL (Diffuse Large B-Cell Lymphoma) are allowed if they did not respond or relapsed within 6 months after their first treatment.
  • Patients must agree to use highly effective contraception during the study and for 12 months after the last dose of treatment. This applies to both male and female patients.
  • Female patients of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception throughout the study and for 12 months after the last dose.
  • Male patients must agree not to donate sperm during the study and for 12 months after the last dose.
  • Patients must have a confirmed diagnosis of de novo DLBCL or DLBCL that has transformed from a previously diagnosed indolent lymphoma, such as follicular lymphoma.
  • Patients must have received at least 1 but no more than 3 prior treatments for DLBCL that did not work or the disease came back after the most recent treatment.
  • Patients must have PET positive measurable disease, meaning a specific type of scan shows at least one affected lymph node or lesion of a certain size.
  • Patients should not be intended for HSCT (Hematopoietic Stem Cell Transplantation) or CAR-T cell therapy based on clinical criteria determined by their doctor.
  • Patients must have adequate bone marrow function, which includes specific levels of blood cells like neutrophils, platelets, and hemoglobin.
  • Patients must have circulating lymphocytes at a certain level.
  • Patients must have adequate liver and kidney function, which includes specific levels of liver enzymes, bilirubin, and creatinine clearance.
  • Patients must have an ECOG performance status of 2 or less, which is a scale used to assess how a patient’s disease is affecting their daily living abilities.

Who Cannot Join the Study?

  • Patients who have another type of cancer that is not under control.
  • Patients who have had a heart attack or severe heart problems in the past 6 months.
  • Patients who have an active infection that needs treatment with antibiotics.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to any of the study drugs.
  • Patients who have had a major surgery in the past 4 weeks.
  • Patients who have a condition that affects their ability to absorb food or medicine properly.
  • Patients who have a history of another serious illness that could affect their safety during the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received certain treatments for their lymphoma in the past 2 weeks.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

Other Sites

Site Name City Country Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universita’ Politecnica Delle Marche Ancona Italy
Pratia S.A. Skorzewo Poland
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta Caserta Italy
Iqxnpydb Cymkfa Dkajsrmaofalynurn L'hospitalet De Llobregat Spain
Svmmgsvf Pnpvxpget Sfq z okbx Gdynia Poland
Atbrwci Oyuatmgzotz Orcwpbjr Rbrorgu Vtmzk Sxwim Cxreraly Palermo Italy
Fvjplnmif Plmo Lf Ijvyawrlgztvp Bcztskdjy Dkw Hjhfbemy Umixknneiqbvz Lk Pml Madrid Spain

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

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
01.09.2020
Poland Poland
Not recruiting
01.09.2020
Spain Spain
Not recruiting
01.09.2020

Trial locations

Investigated drugs:

Rituximab is a medication used to treat certain types of cancer, including diffuse large B-cell lymphoma. It works by targeting specific proteins on the surface of cancer cells, helping the immune system to destroy them.

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

Dexamethasone is a type of steroid medication that helps reduce inflammation and suppresses the immune system. It is often used in combination with other cancer treatments to help manage side effects and improve the effectiveness of the therapy.

Platinum refers to a group of chemotherapy drugs that contain the metal platinum. These drugs, such as cisplatin or carboplatin, work by damaging the DNA of cancer cells, which can lead to cell death.

Selinexor is an experimental cancer treatment that works by blocking a protein that helps cancer cells grow and survive. It is being studied to see if it can improve outcomes for patients with relapsed or refractory diffuse large B-cell lymphoma when added to standard chemotherapy regimens.

Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR 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. Patients may experience symptoms such as fever, night sweats, and weight loss. The disease is considered aggressive and requires prompt medical attention.

Trial ID:
2024-513616-95-00
Protocol code:
XPORT-DLBCL-30
NCT ID:
NCT04442022
Trial Phase:
Therapeutic use (Phase IV)

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