Preliminary Activity of Tolinapant in Combination with Oral Decitabine/Cedazuridine
and Oral Decitabine/Cedazuridine Alone in Subjects with
The University of Virginia is conducting a clinical research study for adults ages 18 and over who have relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL). The purpose of this study is to test the safety and efficacy of tolinapant and INQOVI (decitabine and cedazuridine). This is a 3-part study:
• Part 1 (Lead-in) will determine the starting dose of oral decitabine/ cedazuridine tablet
• Part 2 (Phase 1) will help determine the doses and safety of the study drugs in combination
• Part 3 (Phase 2) will determine how the (body) disease responds to the study drug(s)
You will only participate in 1 of the 3 parts of the study. If you participate in phase 1 of the study, you will be assigned at random (by chance, like tossing a coin) to 1 of 2 study treatment arms. If you are assigned to study treatment Arm A, you will receive the tolinapant and oral decitabine with cedazuridine together. If you are assigned to study treatment Arm B, you will receive oral decitabine and cedazuridine as your study treatment. If you participate in phase 2 of the study, you will receive tolinapant in combination with oral decitabine/ cedazuridine.
The amount of time you will be on study drug(s) or be followed up for health information as part of the study depends on how you respond and tolerate the study treatment. You could be in this research study for up to 4 ½ years. Tolinapant is a capsule and will be given orally. Oral decitabine with cedazuridine are given together in one tablet orally.
Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.
Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05403450
Reimbursement - For patients who have to travel more than 50 miles one way to the clinic, the study team may arrange for your hotel, or you may be reimbursed by check up to $175 per night for a hotel. You may also receive up to $.54 cents per mile.