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)
Conditions
Non-Hodgkin's Lymphoma
Phase II
Volunteers
Health Professionals
What is the purpose of this trial?
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 Peripheral T-Cell Lymphoma (PTCL). This study will compare the experimental combination treatment of romidepsin and oral azacytidine to single agent drugs already determined effective in patients with PTCL. For the purposes of this study, the single agent drugs already used to treat lymphoma are called investigator's choice (IC), meaning the investigator will choose which one of these drugs to administer. The IC drug options include romidepsin, belinostat, pralatrexate or gemcitabine given alone. Funding Source: FDA OOPD.
- Trial withUniversity of Virginia
- Start Date03/07/2022
- End Date12/31/2023
I'm interested in volunteering
If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 877.978.8343
Principal Investigator
Sub-Investigators
- Adam Boruchov, MD
- Alexis Walker
- Andrea Brennan
- Armand Russo, MD
- Ashita Talsania, MRCP, MBBS
- Benjamin Newton, MD
- Beverly Drucker, MD, PhD
- Carrie Fijal, MSN, AGPCNP-BC, OCN
- D. Barry Boyd, MD, MS
- Daniel P. Petrylak, MD
- David Witt, MD
- Elan Gorshein, DO, JD, MPH
- Francine Foss, MD
- Harold Tara Jr, MD
- Iris Isufi, MD
- James Vredenburgh, MD
- Jason Haldas, MD
- Jaykumar Thumar, MBBS, MD
- Jean Vollmer
- Jeremy Kortmansky, MD
- Johanna LaSala, MD
- Justin Persico, MD
- Kaitlin Brown
- Katherine Harvey, MD, MPH
- Kathleen Fenn, MD
- Kelsey Martin, MD
- Kert Sabbath, MD, FACP
- Kristen Hoxie
- M. Sung Lee, MD
- Michael Cohenuram, MD
- Neal Fischbach, MD
- Robert Legare, MD
- Sara Anastasio, RN
- Sarah Carlson
- Scott Huntington, MD, MPH, MSc
- Shalin Kothari, MD
- Stephanie Paine, APRN
- Stephen Lattanzi, MD
- Stuart Seropian, MD
- Su Hsien Lim, MD
- Sudhanshu Mulay, MD
- Syed Bilgrami, MBBS
- Tarsheen Sethi, MD, MSCI
- Victor Chang, MD
- Virginia Syombathy
- Wajih Kidwai, MD, FACP
- Last Updated11/11/2022
- Study HIC#2000030190