Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04747236 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL

Study acronym: PTCL
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 5 to 6v12
  2. Primary completion date: Jun 2, 2026 to Jun 2, 2028
    • Study completion date: Jun 2, 2028 to Jun 2, 2030
    v11
  3. Study sites: 4 to 5v10
  4. Primary completion date: Dec 2, 2026 to Jun 2, 2026v9
  5. Primary completion date: Jun 2, 2026 to Dec 2, 2026v8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Jun 2, 2024 to Jun 2, 2026v7
  2. Enrollment target: 74 to 50v6 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2023 to Jun 2, 2024
    • Study completion date: Dec 31, 2026 to Jun 2, 2028
    • Eligibility criteria revised
    • Site contacts updated at 2 of 4 sites
  3. Study sites: 3 to 4v5
  4. Primary completion date: Dec 31, 2022 to Dec 31, 2023v4 Show 4 more changesShow less
    • Study sites: 1 to 3
    • Study completion date: Dec 31, 2022 to Dec 31, 2026
    • Eligibility criteria shortened, about 60 words
    • Study title shortened, about 10 words
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 17, 2021 to Feb 19, 2021
    • Site details revised
    v3
  6. Collaborators: 2 to 1v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04747236
Lead Sponsor University of Virginia
Collaborators: Celgene
Conditions
(from sponsor)		 PTCL
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov