Clinical Trials | A Randomized Phase III Study To Evaluate Benefits of Autologous Stem Cell Transplant in Patients with Peripheral T Cell Lymphoma that Achieved a First Complete Remission (CR1) Following Induction Therapy

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have been diagnosed with Peripheral T-cell Lymphoma and may be eligible for autologous stem cell transplant after response to first line treatment. The purpose of this study is to compare the first line chemotherapy alone followed by observation to using high dose chemotherapy followed by stem cell infusion after completing the usual chemotherapy. Treatment with high dose chemotherapy followed by stem cell transplant could prevent your lymphoma from returning but it has never been proven by a randomized study. This study has two groups: • Group 1: If you are assigned to this group, you will be observed once a year without any additional treatments unless your disease recurs. If that were to occur, you would be treated under your cancer doctor’s guidance, which may also include the possibility of receiving a stem cell transplant as an option if you are eligible for it in this setting. • Group 2: If you are assigned to this group, you will undergo stem cell collection, then you will receive high dose chemotherapy followed by getting your own stem cells as an infusion, this is called an “autologous stem cell transplant”. You will receive the necessary supportive care measures after that until your transplanted stem cells recover. You will then be observed without any additional treatments unless your disease recurs. We will use a computer to assign you to one of the study groups. This process is called “randomization.” It means that your doctor will not choose, and you cannot choose which study group you are in. You will be put into a group by chance. You will have an equal chance of being in Group 1 or Group 2. Your study doctor will follow you to see how you are doing for up to 12 years after treatment. You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your lymphoma. Additional information can be found here: https://clinicaltrials.gov/study/NCT06724237 [email protected]