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Study of Tolinapant with Decitabine and Cedazuridine for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

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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 called Peripheral T-cell Lymphoma (PTCL), which is a cancer of the immune system's T-cells. The study is specifically for patients whose cancer has returned or has not responded to previous treatments, known as relapsed/refractory Peripheral T-cell Lymphoma (R/R PTCL). The trial will test the safety and effectiveness of a new treatment combination. This includes a medication called Tolinapant, which is taken as a capsule, and a combination of two substances, Decitabine and Cedazuridine, which are taken as a tablet.

The purpose of the study is to find out how safe these treatments are and how well they work in treating R/R PTCL. The study will be conducted in two phases. In the first phase, researchers will determine the safest dose of Tolinapant when used with Decitabine/Cedazuridine. In the second phase, they will evaluate how effective the treatment is in reducing the cancer. Participants will receive either the combination of Tolinapant with Decitabine/Cedazuridine or Decitabine/Cedazuridine alone. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects.

Throughout the study, participants will take the medications orally, meaning by mouth. The study will monitor the participants' health and any side effects they may experience. The trial aims to provide valuable information on whether this combination of treatments can help manage R/R PTCL more effectively. The study is expected to continue until 2026, with the goal of improving treatment options for patients with this challenging form of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the patient meets the study criteria.

    A pregnancy test is required for women of childbearing potential. Both men and women must agree to use effective birth control methods during the study and for a specified period after the study ends.

  2. Step 2

    Treatment phase 1

    In the first phase, the patient receives a combination of tolinapant and oral decitabine/cedazuridine. These medications are taken by mouth in the form of tablets and capsules.

    The purpose of this phase is to assess the safety of the treatment and determine the appropriate dosage for the next phase.

  3. Step 3

    Treatment phase 2

    In the second phase, the patient continues to receive the treatment to evaluate its effectiveness. The focus is on measuring the response to the treatment using imaging techniques.

    The patient's health and response to the treatment are closely monitored throughout this phase.

  4. Step 4

    Regular monitoring

    Throughout the study, regular check-ups and tests are conducted to monitor the patient's health and any side effects from the treatment.

    These assessments help ensure the patient's safety and provide data on the treatment's impact.

  5. Step 5

    End of study

    At the end of the study, a final assessment is conducted to evaluate the overall response to the treatment.

    The patient may be asked to continue follow-up visits to monitor long-term effects and gather additional data.

Who can join the trial?

10 criteria

  • Must be able to understand and follow the study rules and procedures, and agree to participate by signing a consent form.
  • Women who can have children must not be pregnant or breastfeeding. They must have a negative pregnancy test before starting the study and agree to use a very effective form of birth control during the study and for 6 months after the last treatment. Men with partners who can have children must use a condom and ensure their partners use a very effective form of birth control during the study and for at least 3 months after the last treatment.
  • Must be 18 years of age or older.
  • Must have a life expectancy of more than 12 weeks.
  • Must have a confirmed diagnosis of relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) according to specific medical classifications.
  • Must show evidence of disease progression and have received at least two previous treatments for their condition.
  • Must have measurable disease as shown by a specific type of imaging test (CT scan).
  • If the disease is CD30-positive, must have received, be ineligible for, or unable to tolerate a specific treatment called brentuximab vedotin, if it is available.
  • Must have an ECOG performance status of 0, 1, or 2, which is a scale used to assess how the disease affects daily living abilities.
  • Must have acceptable organ function as shown by specific laboratory tests, including liver and kidney function tests, and blood cell counts.

Who cannot join the trial?

8 criteria

  • Patients who do not have relapsed/refractory peripheral T-cell lymphoma (R/R PTCL) cannot participate. This means the study is only for those whose specific type of lymphoma has returned or did not respond to treatment.
  • Patients who are not within the specified age range cannot participate. The study is for adults only.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who are unable to provide informed consent cannot participate. This means they must understand the study and agree to take part.
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Investigated drugs

  • Tolinapant

    is a medication being studied for its potential to help treat a type of cancer called peripheral T-cell lymphoma, which is a cancer of the immune system. In this trial, researchers are looking at how safe it is to use and how it works in the body when combined with another treatment. They are also trying to find the best dose to use in future studies.

  • Decitabine/Cedazuridine

    is a combination of two medications taken by mouth. Decitabine is a type of drug that can help stop cancer cells from growing and multiplying. Cedazuridine is included to help decitabine work better by preventing it from being broken down too quickly in the body. This combination is being tested to see how effective it is in treating peripheral T-cell lymphoma, especially in patients whose cancer has returned or has not responded to previous treatments.

What is already known about the treatment

Tolinapant – Tolinapant is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). It is not yet widely used in medicine, as it is still under investigation. The main therapeutic indication for tolinapant is its potential use in combination with other medications to treat certain types of lymphoma. At the molecular level, tolinapant works by inhibiting proteins that help cancer cells survive, thereby promoting cancer cell death. It is classified pharmacologically as an inhibitor of apoptosis proteins.

Investigated diseases

Peripheral T-cell lymphoma – Peripheral T-cell lymphoma is a type of cancer that originates in the T-cells, which are a part of the immune system. It is characterized by the abnormal growth of T-cells, which can spread to lymph nodes and other organs. The disease often begins with symptoms such as swollen lymph nodes, fever, and weight loss. As it progresses, it can affect the skin, liver, and bone marrow. The progression of the disease can vary, with some cases advancing rapidly while others develop more slowly. The exact cause of peripheral T-cell lymphoma is not well understood, but it involves genetic mutations in the T-cells.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-500391-62-00Protocol codeASTX660-03Estimated enrolment157 patientsSponsorTaiho Oncology Inc.

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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).