Trials / Completed
CompletedNCT02181218
Phase I Study of Romidepsin, Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed/Refractory Aggressive Lymphomas
A Multicenter Phase I Dose-finding and Preliminary Efficacy Study of the Histone Deacetylase Inhibitor Romidepsin (Istodax) in Combination With Gemcitabine (Gemzar), Oxaliplatin (Eloxatin), and Dexamethasone for the Treatment of Adults With Relapsed/Refractory Aggressive Lymphomas
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to find the maximum tolerated dose of a drug called romidepsin when given with a treatment regimen called GemOxD. GemOxD is a routine treatment for certain types of lymphoma, and involves the administration of three drugs: gemcitabine, oxaliplatin, and dexamethasone. In addition to finding the maximum tolerated dose of romidepsin, the investigators want to look at the side effects of these drugs when given together, as well as how the lymphoma responds to this treatment.
Conditions
- Lymphoma, T-Cell, Cutaneous
- Lymphoma, T-Cell, Peripheral
- Hodgkin Disease
- Lymphoma, Large B-Cell, Diffuse
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romidepsin | |
| DRUG | Gemcitabine | |
| DRUG | Oxaliplatin | |
| DRUG | Dexamethasone | |
| DRUG | Pegfilgrastim |
Timeline
- Start date
- 2015-02-04
- Primary completion
- 2019-03-28
- Completion
- 2020-06-26
- First posted
- 2014-07-03
- Last updated
- 2020-11-17
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02181218. Inclusion in this directory is not an endorsement.