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Clinical Trial Summary

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.


Clinical Trial Description

Peripheral T-Cell Lymphoma (PTCL) is a rare and heterogeneous group of non-Hodgkin lymphoma (NHL) originating from mature (or post-thymic or 'peripheral') T- lymphocytes and NK cells. They are considered very aggressive and are often resistant to conventional chemotherapy. This study employs a stratified randomization with equal allocation within strata of patients to receive oral 5-azacytidine (AZA) plus romidepsin (ROMI) versus pre-specified investigator choice (ROMI, belinostat, pralatrexate or gemcitabine), for the treatment of relapsed or refractory (R/R) PTCL. The dose and schedule of AZA/ROMI has been determined from a phase I clinical trial of the combination. The primary objective of this study is to estimate the progression free survival (PFS) among patients receiving the combination compared to single agent of choice. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04747236
Study type Interventional
Source University of Virginia
Contact Enrica Marchi, MD
Phone 434-924-9637
Email em5yt@hscmail.mcc.virginia.edu
Status Recruiting
Phase Phase 2
Start date February 19, 2021
Completion date June 2, 2028

See also
  Status Clinical Trial Phase
Recruiting NCT03900442 - Phase 1 Study of PTX-100 in Patients With Advanced Malignancies With PTCL Expansion Cohort Phase 1
Withdrawn NCT02757248 - Ph1 Volasertib Plus Romidepsin in R/R PTCL and CTCL Phase 1
Not yet recruiting NCT05238064 - Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL Phase 1/Phase 2
Recruiting NCT03240211 - Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL Phase 1
Not yet recruiting NCT04705090 - A Study of YY-20394 in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma Phase 2
Completed NCT03493451 - Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms Phase 2
Recruiting NCT05967949 - A Retrospective Clinical Study on the First-line Maintenance Treatment of PTCL With Chidamide.
Recruiting NCT03884205 - GDPE/CEOPE Compared With CEOPE for Newly Diagnosed Patients With PTCL