Ongoing Clinical Trials for Adult T-cell Lymphoma/Leukaemia Recurrent
Currently, there is 1 ongoing clinical trial for adult T-cell lymphoma/leukaemia that has returned after treatment. This trial is investigating a combination of medications including Selinexor, Ifosfamide, Etoposide, and Dexamethasone for patients whose disease has relapsed or not responded to previous treatments. The study is being conducted in Italy and aims to determine how effective this medication combination is in treating this challenging condition.
Clinical trial locations
Study of Selinexor, Ifosfamide, Etoposide, and Dexamethasone for Patients with Relapsed or Refractory Peripheral T-cell Lymphomas
This clinical trial is testing a combination of four medications for patients whose peripheral T-cell lymphoma has either returned after treatment or has not responded to previous therapies. The study is designed to evaluate how well these medications work together to improve patient outcomes.
Who can participate:
To join this study, you must meet several requirements. You need to be between 18 and 75 years old with a confirmed diagnosis of certain types of T-cell lymphomas according to World Health Organization classifications. Your disease must have relapsed or not responded to at least one previous treatment that included an anthracycline drug. You should have measurable disease visible on CT or MRI scans and a life expectancy of at least 3 months. Your organs must function normally, particularly your kidneys, heart, and liver. Your ability to perform daily activities should be reasonably maintained, scoring 2 or less on a performance status scale.
You must be available for treatment and follow-up visits and provide voluntary written consent to participate. Tumor tissue samples from either past tests or newly collected must be available. If you are of childbearing or reproductive potential, you must agree to use effective birth control or abstain from sexual activity during the study and for 90 days after the last dose.
Who cannot participate:
You cannot join this study if your lymphoma has not returned or worsened after previous treatment. Patients younger than 18 or older than 65 are not eligible. If you are pregnant or breastfeeding, you cannot participate. You will be excluded if you cannot safely take the study medications or if you have involvement of the central nervous system at the time of enrollment. A history of psychiatric disease or other serious health conditions that could interfere with the study or make participation unsafe will also prevent enrollment. Additionally, if you are currently participating in another clinical trial, you cannot join this one.
Study focus and goals:
The main goal of this trial is to determine the overall response rate to the medication combination, including both complete and partial responses. The study follows a structured approach: after enrollment and initial assessment including imaging tests and blood work, patients begin treatment cycles. Each cycle includes all four medications administered according to a specific schedule. After completing four treatment cycles, doctors evaluate how well the treatment is working by looking for signs of improvement such as reduction in cancer size or complete disappearance of the cancer. The study also closely monitors any side effects participants may experience. Long-term follow-up continues to track progression-free survival and overall survival.
Investigational drugs:
Selinexor is taken orally as a 20 mg film-coated tablet. This medication works by blocking certain proteins in cancer cells that help them survive, potentially leading to cancer cell death. It is classified as a selective inhibitor of nuclear export and is currently being studied in clinical trials, though it is not yet part of standard treatment.
Ifosfamide is administered as an intravenous solution for infusion. This well-established chemotherapy drug belongs to the class of alkylating agents and works by interfering with the DNA of cancer cells, preventing them from multiplying. It is widely recognized and used in standard cancer treatment protocols.
Etoposide is given as a concentrated solution for infusion. This medication is classified as a topoisomerase inhibitor and works by blocking an enzyme essential for DNA replication in cancer cells, thereby preventing their growth. It is commonly used in various chemotherapy regimens.
Dexamethasone is provided as a solution for injection. This corticosteroid reduces inflammation and suppresses the immune system. It mimics the effects of hormones produced by the adrenal glands and is often used alongside other cancer treatments to help manage side effects and improve treatment effectiveness.
Summary
Currently, only one clinical trial is available for patients with recurrent adult T-cell lymphoma/leukaemia, and it is being conducted exclusively in Italy. This trial focuses on testing a four-drug combination therapy that includes both established chemotherapy agents and a newer investigational medication. The study is specifically designed for patients whose disease has relapsed or proven resistant to previous treatments, offering a potential new treatment option for this challenging condition. Patients interested in participating should discuss eligibility requirements with their healthcare team, particularly noting the age restrictions and the need for adequate organ function.
