Trial · NCT02616965
A Study to Assess the Feasibility of Romidepsin Combined With Brentuximab Vedotin in Cutaneous T-cell Lymphoma
NCT02616965, Phase 1, Completed, Fox Chase Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess the Feasibility of Romidepsin Combined With Brentuximab Vedotin in Cutaneous T-cell Lymphoma. Trials, record NCT02616965. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02616965
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Feasibility of Romidepsin Combined With Brentuximab Vedotin in Cutaneous T-cell Lymphoma
- NCT number
- NCT02616965
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 16 participants, actual
- Lead sponsor
- Fox Chase Cancer Center
- Conditions
- Cutaneous T-cell Lymphoma (CTCL)
- Interventions
- Romidepsin, Brentuximab vedotin
- First posted
- 2015-11-30
- Last updated
- 2025-04-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) | during treatment period which is an average of 64 weeks. | CTCAE v4.03 |
| Primary | Dose-limiting toxicities (DLTs) | during the first 28 days (cycle 1) of treatment | CTCAE v4.03 |
| Secondary | overall safety and tolerability of the combination of brentuximab vedotin & romidepsin assessed by adverse events. | from start of treatment to 30 days post treatment period (16 cycles) | CTCAE v4.03 |
| Secondary | Estimate complete and partial response rate of the combination treatment | 64 weeks, 30 days post treatment and every 12 weeks post-treatment, up to 2 years | mSWAT skin assessment |
| Secondary | Estimate complete and partial response rate of the combination treatment | 64 weeks, 30 days post treatment and every 12 weeks post-treatment, up to 2 years | Global Response Score (GRS). |
| Secondary | Overall survival (OS) | From the time of patient registration until death, measured every 12 weeks up to 2 years | OS is measured by length of time |
| Secondary | Progression free survival (PFS) | From the time of patient registration until disease progression, measured every 12 weeks up to 2 years | PFS is measured in length of time by RECIST v1.1 |
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/NCT02616965
GET https://conductscience.org/api/trials/v1/NCT02616965/registered