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Study on the Effectiveness and Safety of Belinostat and Pralatrexate with Drug Combination for Newly Diagnosed Peripheral T-Cell Lymphoma Patients

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 called Peripheral T-Cell Lymphoma (PTCL). The study aims to evaluate the safety and effectiveness of different treatment combinations for patients who have been newly diagnosed with this condition. The treatments being tested include a combination of drugs known as Bel-CHOP and Fol-COP. The Bel-CHOP regimen includes the drug Belinostat along with a standard chemotherapy regimen called CHOP, which consists of Cyclophosphamide, Doxorubicin, Vincristine Sulfate, and Prednisone. The Fol-COP regimen includes the drug Pralatrexate combined with a modified version of the CHOP regimen, excluding Doxorubicin.

The purpose of the study is to determine which treatment combination is more effective in improving the progression-free survival of patients, which means the length of time during and after treatment that a patient lives with the disease without it getting worse. The study will be conducted in two parts. The first part will focus on finding the best dose levels for Belinostat and Pralatrexate when used with the CHOP regimen. The second part will compare the effectiveness and safety of the Bel-CHOP and Fol-COP combinations against the CHOP regimen alone. Patients will receive treatment for up to six cycles, and their health will be monitored to assess the outcomes.

Participants in the study will receive their treatments through intravenous methods, which means the medication will be delivered directly into a vein. The study will also involve regular check-ups and assessments to monitor the patients' response to the treatment and any side effects they may experience. The ultimate goal is to find a more effective treatment option for patients with newly diagnosed Peripheral T-Cell Lymphoma, potentially improving their quality of life and survival rates.

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

    Joining the study

    Upon joining the study, the patient is confirmed to have a diagnosis of peripheral T-cell lymphoma. The patient must meet specific criteria, including having measurable disease and a performance status that allows participation.

  2. Step 2

    Part 1: dose finding

    The initial phase involves determining the appropriate dose levels for the medications belinostat and pralatrexate when used with the CHOP regimen. This phase focuses on safety and the response rate at three months.

  3. Step 3

    Part 2: treatment

    The patient receives treatment for up to six cycles. The treatment options include Bel-CHOP (belinostat with CHOP) or Fol-COP (pralatrexate with COP), compared to CHOP alone.

    The CHOP regimen consists of the following medications: doxorubicin, cyclophosphamide, vincristine sulfate, and prednisone. Doxorubicin, cyclophosphamide, and vincristine sulfate are administered intravenously, while prednisone is taken orally.

  4. Step 4

    Monitoring and evaluation

    Throughout the treatment, the patient's progress is monitored. The primary goal is to assess progression-free survival, which measures the time from the start of treatment until the disease progresses or the patient passes away.

    Secondary evaluations include overall survival, which tracks the time from treatment initiation until death from any cause, and the objective response rate, which measures the percentage of patients achieving a complete or partial response.

  5. Step 5

    Completion of treatment

    After completing the treatment cycles, the patient's health and response to the treatment are thoroughly assessed. The study aims to determine the most effective treatment regimen for newly diagnosed peripheral T-cell lymphoma.

Who can join the trial?

10 criteria

  • The patient must have been newly diagnosed with a type of cancer called **Peripheral T-Cell Lymphoma (PTCL)** and not have received any treatment for it yet.
  • The patient must have at least one area of cancer that can be measured by doctors using specific guidelines.
  • The patient must have a performance status of 2 or less on a scale used by doctors to assess how well a patient can perform daily activities. This scale is called the **Eastern Cooperative Oncology Group (ECOG) performance status**.
  • For the first part of the study, the patient must have adequate blood, liver, and kidney function as defined in the study protocol.
  • For the second part of the study, patients with certain liver or kidney issues related to the disease can be included if the treatment can be given safely according to the study guidelines.
  • The patient's **UGT1A1 genotype** must be known. This is a specific genetic test that may affect how the drug is given.
  • The patient must be willing and able to provide written consent to participate in the study and follow the study's schedule and requirements.
  • The patient must be at least 18 years old.
  • The patient must agree to use two forms of birth control, one of which must be a barrier method, from the start of the study until at least 30 days after the last dose of the study treatment.
  • Women who can become pregnant must have a negative pregnancy test within four weeks before starting the study treatment. Women who have not had a menstrual period for at least one year or who have been surgically sterilized do not need this test.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer than Peripheral T-Cell Lymphoma cannot participate. This is a specific type of cancer that affects certain white blood cells.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for patients within certain age groups.
  • Patients who are not newly diagnosed with Peripheral T-Cell Lymphoma cannot participate. This means the study is for those who have recently found out they have this type of cancer.
  • Patients who are not able to safely receive the study medications cannot participate. This means if the medications could harm the patient, they should not join the study.
  • Patients who are part of a vulnerable population that the study cannot safely include cannot participate. This refers to groups of people who might need special protection in research studies.
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Investigated drugs

  • Beleodaq

    (belinostat) is a medication used in this trial to treat patients with newly diagnosed Peripheral T Cell Lymphoma. It is combined with a chemotherapy regimen known as CHOP, which includes other cancer-fighting drugs. The goal is to see if adding Beleodaq to CHOP improves treatment outcomes.

  • Folotyn

    (pralatrexate injection) is another medication being tested in this trial. It is used in combination with a chemotherapy regimen called COP, which is similar to CHOP but without one of the drugs. The study aims to determine if Folotyn combined with COP is more effective than the standard CHOP regimen alone.

  • CHOP

    is a standard chemotherapy regimen used to treat certain types of lymphoma. It includes a combination of drugs that work together to kill cancer cells and stop them from growing. In this trial, CHOP is used as a comparison to see if adding Beleodaq or Folotyn provides better results.

  • COP

    is a chemotherapy regimen similar to CHOP but does not include one of the drugs found in CHOP. It is used in combination with Folotyn in this trial to evaluate its effectiveness compared to the standard CHOP regimen.

What is already known about the treatment

  • Beleodaq

    Beleodaq is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Peripheral T-Cell Lymphoma. It is used in combination with the CHOP regimen, which is a standard chemotherapy treatment. Beleodaq works by inhibiting enzymes that modify proteins, leading to the death of cancer cells. It is classified as a histone deacetylase inhibitor.

  • Folotyn

    Folotyn is given as an injection and is under investigation for its role in treating Peripheral T-Cell Lymphoma. It is combined with the COP regimen, a chemotherapy protocol. Folotyn acts by interfering with the DNA synthesis of cancer cells, preventing their growth and division. It belongs to the class of antifolate chemotherapy agents.

Investigated diseases

Peripheral T-Cell Lymphoma – Peripheral T-Cell Lymphoma is a type of cancer that originates in the T-cells, which are part of the immune system. It is characterized by the abnormal growth of these cells, which can occur in lymph nodes, skin, liver, or spleen. The disease often presents with symptoms such as swollen lymph nodes, fever, weight loss, and night sweats. As it progresses, it can affect various organs and tissues, leading to a range of symptoms depending on the areas involved. The progression of the disease can vary, with some cases advancing more rapidly than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-507803-76-00Protocol codeSPI-BEL-301Estimated enrolment509 patientsSponsorAcrotech Biopharma Inc.

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