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Study of Romidepsin and Drug Combination for Young Patients with Peripheral T-Cell Lymphomas Before Stem Cell Transplantation

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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 certain types of lymphoma, which is a cancer of the lymphatic system. The specific types being studied are Anaplastic Large T-cell Lymphoma ALK negative, Angioimmunoblastic T-cell Lymphoma, and Peripheral T-cell Lymphoma, NOS. The treatment being tested is a combination of a drug called Romidepsin and a chemotherapy regimen known as CHOEP. Romidepsin is a type of medication that is given as a solution for injection and works by inhibiting certain enzymes in cancer cells, which may help to stop their growth.

The purpose of this study is to evaluate the safety and effectiveness of this treatment combination as a first-line therapy before a procedure called hematopoietic stem cell transplantation, which is a type of treatment that replaces damaged or destroyed bone marrow with healthy bone marrow stem cells. The study is divided into two phases. In the first phase, the focus is on determining the safest dose of the treatment combination. In the second phase, the study aims to assess how well the treatment works in terms of preventing the cancer from getting worse or coming back.

Participants in the study will receive the treatment combination and will be monitored over time to see how their cancer responds to the treatment. The study will also look at the overall response rate, which measures how many patients experience a reduction in cancer size or symptoms, and the overall survival rate, which tracks how long patients live after starting the treatment. The study is expected to continue until March 2025, with ongoing assessments to ensure the safety and effectiveness of the treatment.

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 study

    Upon joining the study, you will be informed about the trial's purpose and procedures. You will be required to provide written informed consent, confirming your understanding and agreement to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet the eligibility criteria. This includes checking your age, health status, and medical history. Tests may include blood tests, heart function tests, and lung function tests.

  3. Step 3

    Treatment phase i

    In Phase I, the goal is to determine the maximum tolerated dose of the treatment combination called Ro-CHOEP-21. You will receive romidepsin as a solution for injection through a vein (intravenous). The dosage and frequency will be adjusted based on your response and any side effects experienced.

  4. Step 4

    Treatment phase ii

    In Phase II, the focus is on evaluating the effectiveness of the treatment in preventing disease progression. You will continue to receive the Ro-CHOEP-21 treatment. Your health will be monitored regularly to assess the treatment's impact on your condition.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, regular monitoring will be conducted to track your health and any side effects. This includes scheduled visits for physical exams, blood tests, and other necessary assessments. The trial team will provide guidance on managing any side effects.

  6. Step 6

    End of trial

    At the end of the trial, a final assessment will be conducted to evaluate your overall health and the treatment's effectiveness. You will receive information on any further steps or follow-up care needed.

Who can join the trial?

17 criteria

  • Age between 18 and 65 years.
  • Blood tests showing levels of certain substances (serum bilirubin, alkaline phosphatase, and transaminases) less than twice the upper normal limit, unless related to the disease.
  • No psychiatric illness that prevents understanding the trial or signing the consent form.
  • Heart function with an ejection fraction greater than 50% and no recent heart attack or specific heart rhythm issues (QTc interval less than 480 msec).
  • Kidney function with creatinine clearance greater than 60 ml/min, unless related to the disease.
  • Lung function with a diffusion capacity (DLCO) greater than 50%.
  • No active, uncontrolled infection.
  • If of child-bearing potential, agreement to use effective birth control methods before, during, and for 90 days after the study.
  • Availability of tissue samples for review and studies.
  • Diagnosis of specific types of T-cell lymphomas: PTCL-NOS, AITL, ALK negative ALCL.
  • Cancer stage between II and IV.
  • Signed written informed consent.
  • No previous treatment for lymphoma.
  • No disease affecting the brain or spinal cord (Central Nervous System).
  • Negative for HIV.
  • No active hepatitis C virus (HCV) infection.
  • Negative for hepatitis B virus (HBV) or specific conditions with mandatory preventive treatment (Lamivudine).

Who cannot join the trial?

3 criteria

  • Patients with **Anaplastic Large T-cell Lymphoma ALK negative** cannot participate.
  • Patients with **Angioimmunoblastic T-cell Lymphoma** cannot participate.
  • Patients with **Peripheral T-cell lymphoma, NOS** cannot participate.
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Investigated drugs

  • Romidepsin

    is a medication used in this clinical trial to treat a type of cancer called nodal peripheral T-cell lymphoma. It works by interfering with the growth of cancer cells, which may slow down or stop their spread in the body. In this study, Romidepsin is combined with other treatments to see if it can improve the outcomes for patients who are receiving it as a first-line treatment before undergoing a stem cell transplant.

  • CHOEP

    is a combination of chemotherapy drugs used to treat certain types of cancer, including lymphomas. CHOEP stands for Cyclophosphamide, Doxorubicin, Vincristine, Etoposide, and Prednisone. Each of these drugs works in a different way to stop the growth of cancer cells. Cyclophosphamide and Doxorubicin damage the DNA of cancer cells, Vincristine interferes with cell division, Etoposide blocks a specific enzyme needed for cancer cell growth, and Prednisone is a steroid that helps reduce inflammation and can also kill cancer cells. In this trial, CHOEP is used alongside Romidepsin to see if the combination is more effective in treating the lymphoma before a stem cell transplant.

What is already known about the treatment

Romidepsin – Romidepsin is administered intravenously, meaning it is given through a vein, typically in a hospital or clinical setting. It is currently being studied in combination with other drugs as a first-line treatment for certain types of T-cell lymphomas, which are rare forms of blood cancer. The main therapeutic indications for Romidepsin include Anaplastic Large T-cell Lymphoma ALK negative, Angioimmunoblastic T-cell Lymphoma, and Peripheral T-cell lymphoma, NOS. At the molecular level, Romidepsin works by inhibiting enzymes that modify proteins involved in cell growth, leading to the death of cancer cells. It is classified as a histone deacetylase inhibitor, a type of drug that affects how genes are expressed in cells.

Investigated diseases

  • Anaplastic Large T-cell Lymphoma ALK negative

    This is a type of non-Hodgkin lymphoma that affects T-cells, which are part of the immune system. It is characterized by the absence of the anaplastic lymphoma kinase (ALK) protein. The disease typically presents with symptoms such as swollen lymph nodes, fever, and weight loss. It can progress by spreading to other parts of the body, including the skin, lungs, and liver. The progression involves the rapid growth of abnormal T-cells, which can lead to organ dysfunction. The disease is aggressive and requires careful monitoring.

  • Angioimmunoblastic T-cell Lymphoma

    This is a rare and aggressive form of non-Hodgkin lymphoma that originates from T-cells. It is characterized by systemic symptoms such as fever, night sweats, and weight loss, along with generalized lymphadenopathy. The disease progresses by affecting the immune system, leading to immune dysfunction and increased susceptibility to infections. It can also cause skin rashes and autoimmune disorders. The progression involves the proliferation of atypical lymphoid cells and can affect multiple organs. The disease often leads to significant immune system impairment.

  • Peripheral T-cell Lymphoma, NOS

    This is a diverse group of aggressive lymphomas that originate from mature T-cells. "NOS" stands for "not otherwise specified," indicating that the lymphoma does not fit into other specific categories. The disease typically presents with symptoms such as enlarged lymph nodes, fever, and weight loss. It progresses by spreading to various parts of the body, including the liver, bone marrow, and skin. The progression involves the uncontrolled growth of abnormal T-cells, which can disrupt normal organ function. The disease is known for its aggressive nature and complex clinical presentation.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-511639-83-00Protocol codeFIL_PTCL13Estimated enrolment125 patientsSponsorFondazione Italiana Linfomi Ets

sourced from the EU Clinical Trials Register and site verification

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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).