Angioimmunoblastic T-cell lymphoma Trials in Disease

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

This clinical trial is investigating a new treatment combination for patients with angioimmunoblastic T-cell lymphoma and other related types of peripheral T-cell lymphomas. The study is being conducted in Italy and focuses on using this treatment before patients undergo hematopoietic stem cell transplantation, a procedure that replaces damaged bone marrow with healthy stem cells.

Main focus and goal: The trial aims to evaluate both the safety and effectiveness of combining romidepsin with a chemotherapy regimen called CHOEP as a first-line treatment. The study is divided into two phases. Phase I focuses on determining the safest dose of the treatment combination, while Phase II assesses how well the treatment works in preventing the disease from progressing or returning. Researchers will monitor how patients' cancer responds to the treatment and track both the overall response rate and survival rate.

Investigational drugs: The trial uses romidepsin, a medication given as an injection into a vein that works by inhibiting certain enzymes in cancer cells, potentially slowing their growth. It is combined with CHOEP, a chemotherapy regimen consisting of five drugs: Cyclophosphamide, Doxorubicin (also known as Hydroxydaunorubicin), Vincristine (Oncovin), Etoposide, and Prednisone. Each of these drugs attacks cancer cells in different ways, working together to stop cancer cell growth and division.

Who can participate: The trial is open to patients between 18 and 65 years of age who have been newly diagnosed with specific types of T-cell lymphomas, including angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma NOS, or ALK-negative anaplastic large cell lymphoma. Participants must have disease at stage II to IV and have not received any previous treatment for lymphoma. Important eligibility requirements include adequate heart function with an ejection fraction greater than 50%, kidney function with creatinine clearance greater than 60 ml/min, and lung function with diffusion capacity greater than 50%. Patients must also have blood test results showing liver function values less than twice the upper normal limit, unless related to the disease itself. The trial requires tissue samples to be available for review and study purposes. Patients must be HIV-negative and either negative for hepatitis B and C or meet specific conditions for hepatitis B with preventive treatment. Those of child-bearing potential must agree to use effective birth control before, during, and for 90 days after the study. Patients should not have active uncontrolled infections, disease affecting the brain or spinal cord, or psychiatric illness that would prevent understanding the trial or providing informed consent.

Who cannot participate: Despite the trial including angioimmunoblastic T-cell lymphoma in its scope, there appears to be contradictory information in the exclusion criteria section. Patients should discuss eligibility carefully with the trial team to clarify participation requirements.