Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study of Rituximab, Gemcitabine, Dexamethasone, and Platinum with or without Selinexor for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

14 criteria

  • 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 trial?

10 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

  • Rituximab

    This medication is administered intravenously and is used in the treatment of certain types of cancer, including Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL). Rituximab is a monoclonal antibody that targets the CD20 protein found on the surface of B-cells, leading to their destruction. It is classified as an anti-CD20 monoclonal antibody and is well-established in medical literature for its effectiveness in treating B-cell lymphomas.

  • Gemcitabine

    Administered intravenously, gemcitabine is used in combination therapies for various cancers, including RR DLBCL. It works by interfering with DNA synthesis, thereby inhibiting cancer cell growth. Gemcitabine is classified as an antimetabolite and is widely recognized in medical literature for its role in cancer treatment.

  • Dexamethasone

    This medication is taken orally or intravenously and is used to reduce inflammation and suppress immune responses in conditions like RR DLBCL. Dexamethasone is a corticosteroid that works by mimicking the effects of hormones produced by the adrenal glands. It is well-documented in medical literature for its anti-inflammatory and immunosuppressive properties.

  • Platinum-based drugs

    These are administered intravenously and are used in combination with other medications to treat cancers such as RR DLBCL. They work by forming cross-links in DNA, which prevents cancer cells from dividing. Platinum-based drugs are classified as alkylating agents and are well-established in medical literature for their effectiveness in cancer therapy.

  • Selinexor

    Taken orally, selinexor is used in combination with other drugs for treating RR DLBCL. It works by inhibiting the export of tumor suppressor proteins from the nucleus, leading to cancer cell death. Selinexor is classified as a selective inhibitor of nuclear export (SINE) and is currently being studied in clinical trials for its potential benefits in cancer treatment.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-513616-95-00Protocol codeXPORT-DLBCL-30Estimated enrolment60 patientsSponsorKaryopharm Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).