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Study on the Benefits of Autologous Stem Cell Transplantation for Patients with Peripheral T-cell Lymphoma Using Etoposide and Drug Combination

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 cancer called Peripheral T-cell lymphoma (PTCL). The trial is investigating the potential benefits of a treatment called autologous stem cell transplantation (ASCT) for patients who have achieved a complete response after initial chemotherapy. The study aims to determine if this treatment can help prolong the time patients remain free from cancer progression.

Participants in the study will receive a combination of medications as part of their treatment. These medications include Etoposide, Methylprednisolone, Prednisone, Brentuximab vedotin, Doxorubicin, Vincristine, and Cyclophosphamide. Some of these medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein, while others are taken orally as tablets or capsules. The study also involves the use of a placebo for comparison purposes.

The trial will follow participants over a period of time to monitor their response to the treatment and to assess the duration of their response. The goal is to gather information on how effective the treatment is in extending the time patients remain free from cancer progression and to evaluate overall survival rates. This study is an important step in understanding how to improve treatment outcomes for patients with Peripheral T-cell lymphoma.

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, performing physical examinations, and conducting necessary laboratory tests.

    The purpose of this assessment is to ensure that the patient meets all the criteria required to participate in the trial.

  2. Step 2

    Induction chemotherapy

    The patient begins the induction chemotherapy phase, which consists of six cycles of treatment. This phase aims to achieve a complete response in patients with peripheral T-cell lymphoma.

    Medications administered during this phase include etoposide, methylprednisolone hemisuccinate, prednisone, brentuximab vedotin, doxorubicin hydrochloride, vincristine sulfate, and cyclophosphamide monohydrate. These are given through intravenous infusion or oral use, depending on the specific medication.

  3. Step 3

    Response evaluation

    After completing the induction chemotherapy, the patient's response to the treatment is evaluated using imaging techniques such as PET-CT or CT scans.

    The evaluation determines whether the patient has achieved a complete response, which is necessary to proceed to the next stage of the trial.

  4. Step 4

    Autologous stem cell transplantation

    If a complete response is achieved, the patient undergoes autologous stem cell transplantation. This procedure involves collecting the patient's own stem cells, which are then reintroduced into the body after intensive chemotherapy.

    The goal of this transplantation is to prolong progression-free survival, which means extending the time during which the disease does not worsen.

  5. Step 5

    Follow-up and monitoring

    After the transplantation, the patient enters a follow-up phase where regular monitoring is conducted to assess overall health and detect any signs of disease progression.

    This phase includes routine medical check-ups, imaging tests, and laboratory assessments to ensure the patient's well-being and to evaluate the long-term effects of the treatment.

Who can join the trial?

15 criteria

  • Patient must be between 18 and 70 years old at the time of signing the informed consent form.
  • Patient must understand and voluntarily sign and date an informed consent form before any study-specific assessments or procedures are conducted.
  • Patient must be able to follow the study visit schedule and other protocol requirements.
  • Patient must be covered by any social security system.
  • Patient must understand and speak one of the country's official languages.
  • Males with partners who can become pregnant must agree to use effective birth control methods during the study and for 6 months after the last treatment.
  • Females who can become pregnant must agree to use effective birth control methods for at least 28 days before starting treatment, while participating in the study, during treatment interruptions, and for 12 months after the last treatment.
  • Patient must be fit enough to receive an autologous stem cell transplant as a consolidation strategy, as assessed by the local investigator. (This is a procedure where a patient's own stem cells are used to replace damaged or destroyed bone marrow.)
  • Patient must have a hemoglobin level greater than 8g/dL (transfusion allowed), neutrophil count greater than 0.5 G/L, and platelets count greater than 50 G/L (transfusion allowed). (These are measures of blood health.)
  • Patient must have a confirmed diagnosis of nodal-type peripheral T-cell lymphoma (PTCL), not previously treated. This includes specific subtypes as defined by the WHO classification.
  • Patient must have Ann Arbor staging (I-IV) except stage I with normal LDH and PS<2 (i.e., stage I aaIPI 0). (This is a system used to describe the extent of lymphoma.)
  • Patient must have a measurable disease by the Lugano criteria. (This means the disease can be measured by specific medical imaging criteria.)
  • A FFPE Diagnostic tissue block should be available for central pathology review and additional molecular analyses. (This is a sample of tissue preserved for detailed examination.)
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. (This is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.)
  • Patient must have an estimated minimum life expectancy of 3 months.

Who cannot join the trial?

6 criteria

  • Patients who have not reached a complete response after 6 cycles of induction chemotherapy. A complete response means that there are no signs of cancer in the body after treatment.
  • Patients who have not undergone a PET-CT or CT scan to confirm their response to treatment. A PET-CT is a type of imaging test that helps show how tissues and organs are functioning, while a CT scan is a detailed X-ray of the inside of the body.
  • Patients who are not diagnosed with Peripheral T-cell lymphoma (PTCL).
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not able to provide informed consent or are part of a vulnerable population that requires special protection.
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Investigated drugs

Autologous Stem Cell Transplantation (ASCT) is a therapy where a patient's own stem cells are collected and then given back to them after they have received high doses of chemotherapy. This process helps the body to recover and produce healthy blood cells again. In this trial, ASCT is being studied to see if it can help patients with T-cell lymphoma live longer without the disease getting worse after they have responded well to initial chemotherapy.

What is already known about the treatment

Autologous Stem Cell Transplantation (ASCT) – This treatment involves collecting and using a patient's own stem cells to help restore their bone marrow after intensive chemotherapy. It is currently being studied in clinical trials for its effectiveness in treating peripheral T-cell lymphoma (PTCL), a type of blood cancer. The main goal is to see if ASCT can help patients live longer without the disease getting worse after they have responded well to initial chemotherapy. ASCT works by replacing damaged or destroyed bone marrow with healthy stem cells, which can then grow and produce new blood cells. It is classified as a type of regenerative therapy.

Investigated diseases

Peripheral T-cell lymphoma (PTCL) – Peripheral T-cell lymphoma is a type of non-Hodgkin lymphoma that originates from mature T-cells. It is characterized by the abnormal growth of T-cells, which are a type of white blood cell, in the lymphatic system. The disease often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. As it progresses, PTCL can spread to other parts of the body, including the liver, bone marrow, and skin. The progression of the disease can vary, with some forms being more aggressive than others. PTCL is typically diagnosed through a combination of physical examination, imaging studies, and biopsy of affected tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501710-62-02Protocol codeTRANSCRIPTEstimated enrolment204 patientsSponsorLysarc

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