Trial · NCT04747236
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
NCT04747236, Phase 2, Recruiting, University of Virginia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL. Trials, record NCT04747236. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04747236
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
- NCT number
- NCT04747236
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- University of Virginia
- Conditions
- PTCL
- Interventions
- Azacytidine, Romidepsin, Belinostat, Pralatrexate, Gemcitabine
- First posted
- 2021-02-10
- Last updated
- 2026-01-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression free survival | Day of randomization to day of progression or death, whichever comes first; or date of last disease assessment or date of transition to other treatment for those without an event, up to 72 weeks. | Difference in progression free survival in subjects treated with AZA/ROMI versus pre-specified investigator choice. |
| Secondary | Overall survival | Day of randomization to day of death, whichever comes first; or date of last contact for those without an event, up to 72 weeks. | Difference in overall survival in subjects treated with AZA/ROMI versus pre-specified investigator choice. |
| Secondary | Complete response rate | Day of first objective response to 8 weeks following last dose of study treatment | Difference in complete response (CR) rate in subjects treated with AZA/ROMI versus pre-specified investigator choice, based on the Revised Criteria for Response Assessment. |
| Secondary | Overall response rate | Day of first objective response to 8 weeks following last dose of study treatment | Difference in overall response (OR) rate in subjects treated with AZA/ROMI versus pre-specified investigator choice, based on the Revised Criteria for Response Assessment. |
| Secondary | Duration of response rate | Day of first objective response to day of progression or death, whichever comes first; or date of last disease assessment or date of transition to other treatment for those without an event, up to 72 weeks. | Difference in duration of response (DOR) rate in subjects treated with AZA/ROMI versus pre-specified investigator choice, based on the Revised Criteria for Response Assessment. |
| Secondary | Time to progression | Day of randomization to day of progression, or date of last disease assessment or date of transition to other treatment for those without an event, up to 72 weeks. | Difference in time to progression in subjects treated wtih AZA/ROMI versus pre-specified investigator choice. |
| Secondary | Frequency of adverse events | From time of informed consent until 90 days after the last day of study treatment for all adverse events or anytime for serious adverse events considered related to the study intervention, through study completion, an average of 18 months. | Frequency of adverse events in subjects treated wtih AZA/ROMI versus prespecified investigator choice assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40932107 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04747236
GET https://conductscience.org/api/trials/v1/NCT04747236/registered