Trial · NCT02181218
Phase I Study of Romidepsin, Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed/Refractory Aggressive Lymphomas
NCT02181218, Phase 1, Completed, Washington University School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I Study of Romidepsin, Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed/Refractory Aggressive Lymphomas. Trials, record NCT02181218. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02181218
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Study of Romidepsin, Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed/Refractory Aggressive Lymphomas
- NCT number
- NCT02181218
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell, Peripheral, Hodgkin Disease, Lymphoma, Large B-Cell, Diffuse
- Interventions
- Romidepsin, Gemcitabine, Oxaliplatin, Dexamethasone, Pegfilgrastim
- First posted
- 2014-07-03
- Last updated
- 2020-11-17
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 (recommended Phase II dose) | 37 months (completion of first cycle of all participants in study) | Three participants will be treated at each dose level. If 0/3 patients experience dose limiting toxicity (DLT), 3 patients will be treated at the next dose level. If a DLT attributable to the treatment is experienced in 1 of 3 patients, three more patients (for a total of six participants) will be treated at that dose level. If no additional DLTs are observed at the expanded dose level (i.e. 1 of 6 with DLT), the dose will be escalated. Escalation will terminate as soon as two or more participants experience any DLT attributable to study combination, at a given dose level. If 2 or more DLTs occur at the starting dose level, a decreased dose level will be explored at dose level -1. There will be no more than 2 patients dosed for the first time within the same week, and patients in the next higher cohorts will not be enrolled until the last patient of the lower cohort has completed the DLT monitoring period, defined as 21 days after first dose of Cycle 1 therapy. |
| Secondary | Complete response rate | Up to 1 year from time of maximal response | For study participants with relapsed/refractory peripheral T-cell lymphoma (PTCL), diffuse large b-cell lymphoma (DLBCL), and Hodgkin's lymphoma response will be assessed in accordance with the updated International Working Group (IWG) recommendations. For study participants with cutaneous t-cell lymphoma (CTCL), the Global Response Score established by the ISCL/USCLC/EORTC consensus panel will be used to assess response to treatment. |
| Secondary | Partial response rate | Up to 1 year from time of maximal response | For study participants with relapsed/refractory peripheral T-cell lymphoma (PTCL), diffuse large b-cell lymphoma (DLBCL), and Hodgkin's lymphoma response will be assessed in accordance with the updated International Working Group (IWG) recommendations. For study participants with cutaneous t-cell lymphoma (CTCL), the Global Response Score established by the ISCL/USCLC/EORTC consensus panel will be used to assess response to treatment. |
| Secondary | Overall response rate | Up to 1 year from time of maximal response | For study participants with relapsed/refractory peripheral T-cell lymphoma (PTCL), diffuse large b-cell lymphoma (DLBCL), and Hodgkin's lymphoma response will be assessed in accordance with the updated International Working Group (IWG) recommendations. For study participants with cutaneous t-cell lymphoma (CTCL), the Global Response Score established by the ISCL/USCLC/EORTC consensus panel will be used to assess response to treatment. Overall response rate = complete response + partial response |
| Secondary | Progression free survival | Up to 1 year from time of maximal response | Progression-free survival (PFS) will be defined as the time from registration until disease progression. |
| Secondary | Duration of response | Up to 1 year from time of maximal response |
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 |
|---|---|
| 39725584 | 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/NCT02181218
GET https://conductscience.org/api/trials/v1/NCT02181218/registered