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)
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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.
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Principal Investigator
Sub-Investigators
- Adam Boruchov, MD
- Alexis Walker
- Alfredo Axtmayer
- Anca Bulgaru, MD
- Andrea Brennan
- Armand Russo, MD
- Ashita Talsania, MRCP, MBBS
- Benjamin Newton, MD
- Beverly Drucker, MD, PhD
- Catherine Wei, MD
- 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
- Larisa Fleysher
- M. Sung Lee, MD
- Michael Cohenuram, MD
- Neal Fischbach, MD
- Renee Moye
- Robert Legare, MD
- Sara Anastasio, RN
- Sarah Carlson
- Sarah Thomen, APRN
- Scott Huntington, MD, MPH, MSc
- Shalin Kothari, MD
- Stacey LaRosa
- Stephanie Paine, APRN
- Stephen Lattanzi, MD
- Stuart Seropian, MD
- Su Hsien Lim, MD
- Sudhanshu Mulay, MD
- Syed Ali
- Syed Bilgrami, MBBS
- Tarsheen Sethi, MD, MSc
- Victor Chang, MD
- Virginia Syombathy
- Wajih Kidwai, MD, FACP
- Last Updated04/12/2024
- Study HIC#2000030190