Long-term Use of Romidepsin in Patients With CTCL

Completed

Conditions studied: Cutaneous T-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT02296398

Run by

Northwestern University

People needed

47

Starts

2015-01-01

Expected to finish

2015-08-01

Last updated by the study team

2016-03-11

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with the diagnosis of Cutaneous T-cell Lymphoma who present to the Northwestern Medical Faculty Foundation Dermatology clinic between January 1, 2009 and December 31, 2014
• Stages with more than 20% of bosy surface area affected or higher for MF and SS, and other CTCL variants
• Patients treated with romidepsin
• Between 18 and 89 years

You may not qualify if…

• Patients under 18 and over 89 years
• Patients with the diagnosis of CTCL that did not received romidepsin as a treatment

Where it is running

• Northwestern University Dermatology Department — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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