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NCT02296398 · ClinicalTrials.gov registry record
Long-term Use of Romidepsin in Patients With CTCL
A clinical trial of Cutaneous T Cell Lymphoma, sponsored by Northwestern University.
- Completed
- Registry status
- 47
- Enrollment target
- 1
- Study location
NCT02296398: Completed study of Cutaneous T Cell Lymphoma, sponsored by Northwestern University.
NCT02296398 is a study of Cutaneous T Cell Lymphoma that has completed, run by Northwestern University. The registered enrollment target is 47 participants, below the 66-participant average among 23 other Cutaneous T Cell Lymphoma trials with a reported enrollment target (29% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02296398, a study of Cutaneous T Cell Lymphoma, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 47 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
By the time patient received the first cycle the clinical response will be assessed
Conditions Studied
Interventions
- DRUG Romidepsin
Study Locations (1)
Illinois
- Northwestern University Dermatology Department - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2015-01 |
| Est. Completion | 2015-08 |
What the finished NCT02296398 record still lists
NCT02296398 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 66-participant average among 23 other Cutaneous T Cell Lymphoma trials with a reported enrollment target (29% lower).
The record links to 1 condition, with Cutaneous T Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Romidepsin is the first listed.
NCT02296398 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02296398 about?
NCT02296398 is a clinical study titled "Long-term Use of Romidepsin in Patients With CTCL". 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 ar...
What is the current status of trial NCT02296398?
This trial is currently completed. The enrollment target is 47 participants. The study started on 2015-01. Estimated completion is 2015-08.
What conditions does trial NCT02296398 study?
This clinical trial studies the following conditions: Cutaneous T Cell Lymphoma.
What interventions are being tested in trial NCT02296398?
The interventions under investigation include: Romidepsin (DRUG).
Who is sponsoring clinical trial NCT02296398?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02296398 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02296398's enrollment target sits among peer trials
47 10th of 23 higher than 14 of 23 other Cutaneous T Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cutaneous T Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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