Trial · NCT04774068
Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas
NCT04774068, Phase 1, Completed, Walter Hanel
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas. Trials, record NCT04774068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04774068
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas
- NCT number
- NCT04774068
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 5 participants, actual
- Lead sponsor
- Walter Hanel
- Conditions
Recurrent Anaplastic Large Cell Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Transformed Mycosis Fungoides, Refractory Anaplastic Large Cell Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Transformed Mycosis Fungoides, T-Cell Non-Hodgkin Lymphoma
- Interventions
- Parsaclisib, Romidepsin
- First posted
- 2021-02-26
- Last updated
- 2025-01-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of parsaclisib | Cycles 3-5 (each cycle is 28 days) | Will use a time-to-event Bayesian optimal interval design to identify the MTD of this combination regimen. |
| Secondary | Overall response rate (ORR) | Up to 24 weeks | ORR defined as the proportion of patients who achieve a complete or partial response among all evaluable patients. The proportion will be provided with a 95% binomial confidence interval. For mature T-Cell and NK-Cell Non-Hodgkin lymphoma (PTCL) patients, response will be evaluated by the Lugano criteria. For primary cutaneous T-Cell Non-Hodgkin lymphoma (CTCL) patients, responses will be evaluated using the Global Response Score. ORR lasting \>= 4 months will be captured for CTCL patients. |
| Secondary | Duration of response (DOR) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | DOR defined by time to progression; time from the first romidepsin dose until disease progression. |
| Secondary | Progression-free survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | PFS will be calculated from the start of the combination treatment to the time of progression or death, whichever occurs first. Will use the method of Kaplan-Meier to describe these survival endpoints; reporting median or estimates at certain time points with 95% confidence intervals. |
| Secondary | Overall survival (OS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Will use the method of Kaplan-Meier to describe these survival endpoints; reporting median or estimates at certain time points with 95% confidence intervals. |
| Secondary | Disease control rate (DCR) | Up to 2 years | DCR is defined as the proportion of patients with complete response, partial response, or stable disease. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04774068
GET https://conductscience.org/api/trials/v1/NCT04774068/registered