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Study Comparing Duvelisib with Gemcitabine or Bendamustine for Patients with Relapsed or Resistant T Cell Lymphoma Originating from T Follicular Helper Cells

Verified siteRegistered drugNo placebo
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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 blood cancer known as nodal T cell lymphoma, which originates from a specific type of T cells called T follicular helper (TFH) cells. The study is specifically for patients whose cancer has returned after treatment, known as relapsed, or has not responded to previous treatments, known as refractory. The trial will compare the effectiveness of a medication called Duvelisib against two other anti-cancer drugs, Gemcitabine and Bendamustine.

The purpose of the study is to evaluate how well Duvelisib works in extending the time patients live without their disease getting worse, compared to the other two drugs. Participants in the study will be randomly assigned to receive either Duvelisib or the doctor’s choice of Gemcitabine or Bendamustine. Duvelisib is taken orally in the form of hard capsules, while Gemcitabine and Bendamustine are administered intravenously, meaning they are given through a vein. The study will monitor participants over a period of up to three years to assess the progression of the disease and overall survival, as well as the quality of life and any side effects experienced.

This trial aims to provide valuable information on the best treatment options for patients with this type of lymphoma. By comparing these treatments, the study hopes to find the most effective way to manage the disease and improve patient outcomes. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

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

    Joining the trial

    Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive the medication duvelisib, while the other group will receive either gemcitabine or bendamustine, as determined by the study team.

  2. Step 2

    Medication administration

    If you are assigned to the duvelisib group, you will take Copiktra capsules orally. The dosage will be either 15 mg or 25 mg, as prescribed by the study team. You will take these capsules twice daily.

    If you are assigned to the gemcitabine or bendamustine group, these medications will be administered intravenously, meaning they will be given through a vein. The specific dosage and frequency will be determined by the study team.

  3. Step 3

    Regular check-ups

    Throughout the trial, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups will include physical exams, blood tests, and other necessary assessments.

  4. Step 4

    Progress evaluation

    Your progress will be evaluated regularly to determine how the treatment is affecting your condition. This will include assessments of your disease status and any side effects you may experience.

  5. Step 5

    Quality of life assessments

    You will be asked to complete questionnaires about your quality of life. These assessments will help understand the impact of the treatment on your daily activities and overall well-being.

  6. Step 6

    End of trial

    The trial will continue for up to three years, or until the study team determines that it is appropriate to conclude your participation. At the end of the trial, you will have a final evaluation to assess your health and the outcomes of the treatment.

Who can join the trial?

6 criteria

  • Must have a diagnosis of **nodal T cell lymphoma with TFH phenotype**. This includes types like Angioimmunoblastic T cell lymphoma (AITL), follicular T cell lymphoma, and other nodal peripheral T cell lymphomas with a TFH phenotype.
  • The disease must have **come back** (relapsed) or **not responded** (refractory) to at least one previous treatment that involved systemic, cytotoxic therapy for T cell lymphoma.
  • Must have a **measurable disease** as defined by specific medical criteria (Lugano 2014 criteria).
  • Must have an **ECOG Performance Status** of 0, 1, or 2. This is a scale used to assess how a disease affects a patient's daily living abilities, where 0 means fully active and 2 means capable of all self-care but unable to carry out any work activities.
  • Open to both **male and female** participants.
  • Includes participants from **vulnerable populations**.

Who cannot join the trial?

5 criteria

  • Patients who have not experienced a return or worsening of their **nodal T cell lymphoma** with **T follicular helper (TFH) phenotype** cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are not female or male cannot participate.
  • Patients who are not considered part of a vulnerable population cannot participate.
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Investigated drugs

  • Duvelisib

    is a medication used in this clinical trial to treat patients with a type of blood cancer called nodal T cell lymphoma. It works by blocking certain proteins in the body that help cancer cells grow and survive. By doing this, duvelisib can help slow down or stop the progression of the cancer.

  • Gemcitabine

    is another medication used in this trial. It is a type of chemotherapy that helps to kill cancer cells. Gemcitabine works by interfering with the DNA of the cancer cells, preventing them from multiplying and spreading. This can help reduce the size of the cancer and control its growth.

  • Bendamustine

    is also used in this study as a treatment option. It is a chemotherapy drug that attacks cancer cells by damaging their DNA, which stops them from dividing and growing. Bendamustine is used to help manage and reduce the symptoms of the cancer, aiming to improve the patient's quality of life.

What is already known about the treatment

  • Duvelisib

    Duvelisib is taken orally and is currently being studied in clinical trials for its effectiveness in treating a type of cancer called relapsed or refractory nodal T cell lymphoma with T follicular helper (TFH) phenotype. It works by blocking certain proteins in the body that help cancer cells grow, specifically targeting pathways that are crucial for the survival and proliferation of these cancer cells. Duvelisib is classified as a PI3K inhibitor, which means it interferes with the PI3K pathway, a key signaling pathway that cancer cells use to thrive. This medication is being compared to other treatments like gemcitabine and bendamustine to see which is more effective in prolonging the time patients live without their disease getting worse.

  • Gemcitabine

    Gemcitabine is administered through an intravenous infusion, meaning it is given directly into a vein. It is a well-established chemotherapy drug used to treat various types of cancer, including the specific type of lymphoma being studied in this trial. Gemcitabine works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is classified as an antimetabolite, which means it mimics the building blocks of DNA, disrupting the cancer cells' ability to reproduce.

  • Bendamustine

    Bendamustine is also given through an intravenous infusion and is used in the treatment of certain types of cancer, including the lymphoma being investigated in this trial. It acts by damaging the DNA in cancer cells, which stops them from multiplying and eventually leads to their death. Bendamustine is classified as an alkylating agent, a type of chemotherapy that directly attacks the DNA of cancer cells, making it difficult for them to repair and continue growing.

Investigated diseases

Relapsed/Refractory Nodal T Cell Lymphoma with T Follicular Helper (TFH) Phenotype – This is a type of non-Hodgkin lymphoma that originates from T cells, a kind of white blood cell. It specifically involves the T follicular helper cells, which are crucial for the immune system's response. The disease is characterized by the recurrence or persistence of lymphoma after initial treatment. It typically presents with enlarged lymph nodes and can affect other organs. As the disease progresses, it may lead to symptoms such as fatigue, fever, and weight loss. The progression involves the continued growth and spread of cancerous cells in the lymphatic system.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516605-23-00Protocol codeSBI-0145-304Estimated enrolment140 patientsSponsorSecura Bio Limited

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