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 study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy

Other Sites

Site Name City Country Status
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Azienda Unita Sanitaria Locale Di Piacenza Piacenza Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital Santa Maria Della Misericordia Perugia Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Degli Studi Di Verona Verona Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
ARNAS G. Brotzu Cagliari Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Universita Degli Studi Di Brescia Brescia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Aqbcggi Oebtudolxwj Urzsforjertay Prtie Parma Italy
Afnsodv Oyssdnbeesa Ofijwngv Rgvkpan Vflgr Sswow Cwcsbsel Palermo Italy
Ixnjekjv Rbgevbfuz Pva Lu Saffvl Dxh Tqogwo Dujj Ayactgf Ilil Sbxkhh Meldola Italy
Agqrhgr Orcbvdvdmxk Uzlijmmjyvosb Cupxexdifbvo Dsigo Subvnu E Dupwr Syzilyr Da Txarot Turin Italy
Aydyhzx Orbkmrlkyie Nwafiuyva Sz Augsoym E Bxsdsp E C Amxidc Acarzsrzcfn Alexandria Italy
Auktwch Ujr Ikrbw Dw Rvnmsu Erxezh Reggio Emilia Italy
Apkhrmz Ulhwv Sqrjnaokn Lsmkod Dg Bvzuqwl Bologna Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
01.09.2014

Trial locations

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.

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 ID:
2024-511639-83-00
Protocol code:
FIL_PTCL13
NCT ID:
NCT02223208
Trial Phase:
Human Pharmacology (Phase I) – Other

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