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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Hopital Necker Enfants Malades Paris France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Victor Dupouy Argenteuil France
Centre Hospitalier Universitaire De La Reunion St Denis France
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
CHC MontLegia Liege Belgium
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Lyon Sud Pierre Benite France
Grand Hopital De Charleroi Charleroi Belgium
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier De Valenciennes Valenciennes France
Centre Hospitalier D Avignon Avignon France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Institut Jules Bordet Anderlecht Belgium
Centre Hospitalier Regional Universitaire Besançon France
Centre Hospitalier De Roubaix Roubaix France
Centre Hospitalier Alpes Leman 74130 France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Gasthuiszusters Antwerpen Antwerp Belgium
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Metropole Savoie Chambery France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier De Perigueux Perigueux France
Centre Hospitalier De Saint-Quentin Saint Quentin France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Polyclinique Bordeaux Nord Aquitaine Bordeaux France
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Centre Hospitalier Universitaire De Caen Normandie Caen France
L’Hopital Prive Du Confluent Nantes France
L’Hopital Alexandra Lepeve Dunkirk France
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Clqfte Hpuzvqhnaph Useuhnrbgntqb Rwmna Reims France
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Cvpgkx Hjhtlssqjfb Ec Uozcseswqfqrd Dp Lfcvlkf Limoges France
Cbzmzt Hukqdijcoyr Uyeemriepseax Di Dbttb Dijon France
Czykxv Hvaiipwthyd Rcudiuzz Ufpfdnhjfgsod Dr Tltyr Tours France
Cisk Dt Nsyim Vandoeuvre Les Nancy France
Chxvqk Libn Bfrrkv Lyon France
Cwhita Hbhknaijydj Ralnbwkf Ddnymfgibtoibm Angers France
Iayxphhn df Cmeoetubucei Hsxljqigovv Uezcvkyldjhmn dx Sfbvp Enjvkzp (kjozhyf Saint Priest En Jarez France
Hiulaikm Uylynxlqmllygx Sjdezysewc &fzgbxh Hxafuzh dv Hxoejkdpcbt STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
30.07.2022
France France
Recruiting
30.07.2022

Trial locations

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.

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 ID:
2022-501710-62-02
Protocol code:
TRANSCRIPT
NCT ID:
NCT05444712
Trial Phase:
Therapeutic confirmatory (Phase III)

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