Study for Patients with Peripheral T-Cell Lymphoma Comparing an Investigational Combination with Standard Treatment

UVA Tracking #
HSR200080
Principal Investigator
Enrica Marchi
Contact
Aishling Rada
Contact Phone
434.294.9333
Official Trial Title
A Randomized, Phase IIB, Multicenter, Trial of Oral Azacytidine Plus Romidepsin versus Investigator’s Choice in Patients with Relapse or Refractory Peripheral T-cell Lymphoma (PTCL)
Study Description

The University of Virginia Cancer Center is conducting a clinical research study for patients who are adults with peripheral T-cell lymphoma (PTCL) who have received treatment but the treatment either didn’t work or stopped working. The purpose of this study is to find out whether the combination treatment of romidepsin and oral azacytidine is safe and effective in patients with PTCL. Oral azacytidine is approved for use in another type of cancer, but not in PTCL, so this combination is investigational, but previous studies of the combination in PTCL have shown that it is safe and active in PTCL. Half of the participants in this study will receive oral azacytidine and romidepsin, and the other half will receive a standard clinical care drug for PTCL. Treatment assignment will be random and participants will not get to choose.
Participants on the experimental arm will receive oral azacytidine on days 1-14 of each 35 day cycle. and romidepsin an intravenous infusion days 8, 15 and 22 of each 35-day cycle.
Participants on the control arm will receive either 1. romidepsin as an intravenous infusion on days 1, 8, and 15 of a 28 day cycle, 2. belinostat as an intravenous (IV) infusion on days 1-5 every 21 days, 3. pralatrexate as an intravenous (IV) infusion once weekly for 6 weeks of a 7 week cycle, or 4. gemcitabine as an intravenous infusion on days 1, 8, and 15 of a 28 day cycle. For participants randomized to this group, which drug they receive will be decided by their clinician team.
All participants will receive treatment for as long as the treatment is working for them and have research samples collected before, during, and after study treatment is completed. This duration will vary among participants. Participants will still be followed even after they have completed the study treatment. Study-specific tests that are being done beyond standard of care will be provided at no cost to the patient/participant or his/her/their insurance.
Additional information can be found here: PTCL 001 - clinicaltrials.gov

Compensation

This study does not offer compensation or reimbursement.