Trial · NCT03141203
Evaluation of the Combination of Romidepsin and Carfilzomib in Relapsed/Refractory Peripheral T Cell Lymphoma Patients
NCT03141203, Phase 1, Phase 2, Completed, University of Birmingham
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Combination of Romidepsin and Carfilzomib in Relapsed/Refractory Peripheral T Cell Lymphoma Patients. Trials, record NCT03141203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03141203
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Combination of Romidepsin and Carfilzomib in Relapsed/Refractory Peripheral T Cell Lymphoma Patients
- NCT number
- NCT03141203
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- University of Birmingham
- Conditions
- Peripheral T Cell Lymphoma
- Interventions
- Romidepsin, Carfilzomib
- First posted
- 2017-05-05
- Last updated
- 2022-05-18
- Other registries' IDs
- eudract:2013-001879-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose of the combination of romidepsin and carfilzomib | Cycle 1 (each cycle is 28 days) | MTD as determined by the continual reassessment model (CRM) with a predefined target Dose Limiting Toxicity (DLT) probability of 25% |
| Primary | Best overall response rate (PR + CR) at the MTD | Data will be collected over the first 8 cycles of therapy (each cycle is 28 days) | Assessed using the International response criteria |
| Secondary | Toxicity of the combination of romidepsin and carfilzomib | Adverse events information will be collected throughout the 36 month recruitment period of the trial and during the one year follow up period | Assessed using CTCAE v4 |
| Secondary | Best overall response at the MTD | Information relating to this outcome will be collected up to and including the one year follow-up time point | Assessed using International response criteria |
| Secondary | Maximum percentage change in the radiological sum of the product of the diameters from baseline, assessed using the Revised Response Criteria for Malignant Lymphoma | Information relating to this outcome will be collected up to and including the one year follow-up time point | Assessed on suitable target and non-target lesions |
| Secondary | Duration of response from time of first documented response until relapse or progression | Information relating to this outcome will be collected up to and including the one year follow-up time point | |
| Secondary | Progression free survival | Information relating to this outcome will be collected up to and including the one year follow-up time point | |
| Secondary | Overall survival | Information relating to this outcome will be collected up to and including the one year follow-up time point |
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/NCT03141203
GET https://conductscience.org/api/trials/v1/NCT03141203/registered