Chemotherapy + Stem Cell Transplant + Romidepsin for T-Cell Lymphoma

This trial tests the effectiveness of romidepsin (also known as Istodax) for individuals with T-Cell Non-Hodgkin Lymphoma who have already undergone a stem cell transplant. The study aims to determine if romidepsin, when used after high-dose chemotherapy and a stem cell transplant (also known as Autologous Stem Cell Transplant or ASCT), prevents cancer recurrence. It suits those with types of T-cell lymphoma like PTCL or AITL, who are in partial or complete remission, and have collected enough stem cells for the transplant. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

The trial requires that you stop taking medications that cause significant QT prolongation (a heart rhythm issue) and CYP3A4 inhibitors (a type of drug that affects how your body processes certain medications).

Research has shown that high-dose chemotherapy followed by a stem cell transplant using a patient's own cells is generally safe and can extend the lives of those with lymphoma. Studies have found that carmustine-based treatments for this procedure tend to be less harmful and safer than other options.

For romidepsin, used to maintain treatment effects, research indicates that its side effects are usually mild. Common side effects like nausea and tiredness are often not severe. Romidepsin is also approved for treating other types of T-cell lymphoma, suggesting it is safe to use.

Researchers are excited about the combination of high-dose chemotherapy, autologous stem cell transplant, and Romidepsin for T-cell lymphoma because it brings a new approach to tackling this cancer. Unlike standard treatments that primarily involve chemotherapy and radiation, this regimen uses Romidepsin, a drug that inhibits histone deacetylases, potentially reactivating tumor suppressor genes. This unique mechanism of action could enhance the effectiveness of the chemotherapy and stem cell transplant, potentially leading to better outcomes for patients. Additionally, the maintenance therapy with Romidepsin aims to prolong remission, offering hope for longer-lasting results compared to existing treatment protocols.

Research has shown that high-dose chemotherapy followed by a transplant of a patient's own stem cells can effectively treat T-Cell Non-Hodgkin Lymphoma (T NHL). One study found that 56% of patients achieved a complete response, with no detectable cancer. In this trial, participants will receive high-dose chemotherapy with an autologous stem cell transplant, followed by maintenance therapy with the drug romidepsin. Ongoing treatment with romidepsin has kept many patients cancer-free for at least two years post-transplant. This combination aims to eliminate cancer cells and reduce the chance of recurrence. These findings suggest that this treatment approach could be promising for individuals with T NHL.⁶⁷⁸⁹¹⁰