Long-term Use of Romidepsin in Patients With CTCL
Public ClinicalTrials.gov record NCT02296398. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Retrospective and Prospective Study of Long-term Use of Romidepsin in Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Cutaneous T-cell lymphomas (CTCL) are a heterogeneous group of neoplasm of skin-homing T cells that includes Mycosis Fungoid (MF), which is the most common, Sézary syndrome (SS), the leukemia variant of MF, and other variants of CTCL which are less prevalent. Clinical manifestations and prognosis are highly variable. Improving the management of this incurable disease with limited toxicity is the main point of the current research. Romidepsin is a well-tolerated histone deacetylase inhibitor which has demonstrated activity against advanced stages of CTCL. In November 2009, it was approved by the US Food and Drug Administration (FDA) for the treatment of CTCL in patients who have received at least one prior systemic therapy. FDA-dose approved is 14 mg/m2 days 1, 8, 15 of a 21 day-cycle. It is said that it should be continued as long as the patient receives benefit and tolerates the drug. We experienced in our clinic that a long-term (\>6 months) use of Romidepsin, even with spared doses allows patients to maintain disease in complete remission or under control without severe side effects. We aim to demonstrate how many patients have benefited of this maintenance therapy, and detect the side effects related to the long-term use of Romidepsin, as well as characterize those patients that can get benefit of this therapy.
Study identification
- NCT ID
- NCT02296398
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 47 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 89 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2014
- Primary completion
- Jun 30, 2015
- Completion
- Jul 31, 2015
- Last update posted
- Mar 10, 2016
2015
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northwestern University Dermatology Department | Chicago | Illinois | 60611 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02296398, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 10, 2016 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02296398 live on ClinicalTrials.gov.