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Study of Selinexor, Ifosfamide, Etoposide, and Dexamethasone for Patients with Relapsed or Refractory Peripheral T-cell Lymphomas

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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 known as Peripheral T-cell Lymphoma, which has either returned after treatment or has not responded to previous treatments. The study is testing a combination of medications to see how well they work together. The medications being used in this study are Selinexor (also known by its code name KPT-330), Ifosfamide, Etoposide, and Dexamethasone. These medications are being tested together to see if they can help improve the condition of patients with this type of lymphoma.

The purpose of the study is to determine how effective this combination of medications is in treating the lymphoma. Participants in the study will receive these medications over a series of treatment courses. The study will monitor the response of the lymphoma to the treatment, looking for signs of improvement such as a reduction in the size of the cancer or a complete disappearance of the cancer. The study will also keep track of any side effects that participants may experience while taking these medications.

Throughout the study, participants will receive regular check-ups and tests to monitor their health and the progress of the treatment. The study aims to provide valuable information on whether this combination of medications can be a successful treatment option for patients with relapsed or refractory Peripheral T-cell Lymphoma. The results of this study could help improve future treatment options for this challenging condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, the patient provides written informed consent. This consent is necessary before any study-related procedures begin.

    The patient must have a confirmed diagnosis of specific types of T-cell lymphomas and meet other eligibility criteria, such as age and health status.

  2. Step 2

    Initial Assessment

    The patient undergoes a series of assessments to confirm eligibility, including imaging tests like CT or MRI to measure the disease.

    Blood tests are conducted to ensure normal organ function and to establish baseline health metrics.

  3. Step 3

    Treatment Cycle 1

    The patient begins the first cycle of treatment, which includes the administration of several medications.

    Selinexor is taken orally in the form of 20 mg film-coated tablets.

    Ifosfamide is administered as a solution for infusion.

    Etoposide is given as a concentrated solution for infusion.

    Dexamethasone is provided as a solution for injection.

  4. Step 4

    Subsequent Treatment Cycles

    The patient continues with additional treatment cycles, following the same medication regimen.

    Each cycle is monitored closely to assess the patient's response to the treatment and to manage any side effects.

  5. Step 5

    Evaluation of Response

    After completing four treatment cycles, the patient's response to the therapy is evaluated.

    The main objective is to determine the overall response rate, which includes both complete and partial responses.

  6. Step 6

    Follow-up

    The patient undergoes regular follow-up assessments to monitor long-term outcomes, such as progression-free survival and overall survival.

    Adverse events are recorded and managed according to established guidelines.

Who can join the trial?

15 criteria

  • You must provide voluntary written consent to participate, understanding you can withdraw at any time without affecting your future medical care.
  • You need to be available for treatment and follow-up, and willing to meet the study requirements.
  • There must be available samples of your tumor tissue, either from past tests or newly collected.
  • You should have a life expectancy of at least 3 months.
  • You must not have any involvement of the central nervous system (CNS) at the time of joining the study.
  • You should not have a history of psychiatric disease.
  • Your organs should function normally, with specific requirements for kidney function, heart function, and liver enzymes.
  • You need a confirmed diagnosis of certain types of T-cell lymphomas, as classified by the World Health Organization (WHO) in 2016.
  • Your age should be between 18 and 75 years.
  • You must have a measurable disease, which means having at least one lesion that can be detected by specific imaging tests like CT or MRI.
  • Your performance status, which measures your ability to perform daily activities, should be 2 or less on a specific scale.
  • If you are a female of childbearing potential, you should avoid pregnancy by using effective birth control or abstaining from sexual activity during the study and for 90 days after the last dose of the study drug.
  • If you are a male of reproductive potential, you should use effective birth control or abstain from sexual activity during the study and for 90 days after the last dose of the study drug.
  • You must have relapsed or refractory disease after at least one previous treatment for lymphoma that included a specific type of drug called anthracycline.
  • You need to meet certain laboratory test values, including specific levels of blood cells and liver and kidney function tests.

Who cannot join the trial?

7 criteria

  • Patients who have not experienced a return or worsening of their Peripheral T-cell Lymphomas after previous treatment.
  • Patients who are not able to safely take the study medications, which include selinexor, ifosfamide, etoposide, and dexamethasone.
  • Patients who are younger than 18 years old or older than 65 years old.
  • Patients who are part of a vulnerable population, meaning they might not be able to give informed consent or understand the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have other serious health conditions that could interfere with the study or make it unsafe for them to participate.
  • Patients who are currently participating in another clinical trial.
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Investigated drugs

  • Selinexor

    is a medication used in this trial to help treat patients with relapsed or refractory Peripheral T-cell Lymphomas. It works by blocking certain proteins in cancer cells, which can lead to the death of these cells. In this study, it is being tested to see how well it works when used with other cancer treatments.

  • Ifosfamide

    is a chemotherapy drug that is used to treat various types of cancer, including lymphomas. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, it is combined with other medications to see if it can improve treatment outcomes for patients with Peripheral T-cell Lymphomas.

  • Etoposide

    is another chemotherapy medication used in this study. It helps to stop the growth of cancer cells by causing damage to their DNA. This medication is part of the combination therapy being tested to determine its effectiveness in treating relapsed or refractory Peripheral T-cell Lymphomas.

  • Dexamethasone

    is a type of steroid used in this trial to help reduce inflammation and suppress 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. In this study, it is being used alongside other medications to treat Peripheral T-cell Lymphomas.

What is already known about the treatment

  • Selinexor

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory peripheral T-cell lymphomas. It is not yet widely used in standard medical practice but shows promise in ongoing research. Selinexor works by inhibiting a protein that helps cancer cells grow and survive, thereby potentially slowing down or stopping the progression of the disease. It is classified as a selective inhibitor of nuclear export, which targets specific pathways in cancer cells.

  • Ifosfamide

    Administered intravenously, Ifosfamide is a well-established chemotherapy drug used in the treatment of various cancers, including lymphomas. It is widely recognized in medical literature and is part of standard cancer treatment protocols. Ifosfamide works by interfering with the DNA of cancer cells, preventing them from multiplying. It belongs to the class of alkylating agents, which are known for their ability to damage the DNA of cancer cells.

  • Etoposide

    This medication is given either orally or intravenously and is commonly used in the treatment of different types of cancer, including lymphomas. Etoposide is well-documented in medical literature and is a standard part of many chemotherapy regimens. It works by inhibiting an enzyme that is essential for DNA replication in cancer cells, thereby preventing their growth. Etoposide is classified as a topoisomerase inhibitor, targeting specific enzymes involved in DNA replication.

  • Dexamethasone

    Administered orally or intravenously, Dexamethasone is a corticosteroid used to reduce inflammation and suppress the immune system. It is widely used in medical practice for a variety of conditions, including as part of cancer treatment regimens. Dexamethasone works by mimicking the effects of hormones produced by the adrenal glands, helping to reduce inflammation and modulate immune responses. It is classified as a glucocorticoid, which is a type of steroid hormone.

Investigated diseases

Relapsed or Refractory Peripheral T-cell Lymphomas – This is a type of cancer that affects the T-cells, which are a part of the immune system. It occurs when the disease returns after treatment (relapsed) or does not respond to initial therapy (refractory). The lymphomas are characterized by the abnormal growth of T-cells, which can spread to other parts of the body. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing more rapidly than others. The condition requires ongoing monitoring to assess changes in the disease's behavior.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513295-18-00Protocol codePTCL S-IDEEstimated enrolment30 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

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