Long-term Use of Romidepsin in Patients With CTCL

Cutaneous T-cell Lymphoma Clinical Trial

Official title:

Retrospective and Prospective Study of Long-term Use of Romidepsin in Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296398
• Other study ID #: STU95649
• Status: Completed
• Phase: N/A
• First received: October 2, 2014
• Last updated: March 10, 2016
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

This project is a retrospective and prospective chart review of patients who present at Northwestern Medical Faculty Foundation clinic with the diagnosis of CTCL. It includes Mycosis Fungoid, Sézary Syndrome and other subtypes of CTCL, like Cytotoxic Cutaneous T-cell lymphomas. Those patients that received or will be prescribed per standard of care with romidepsin for at least 1 month (or at least more than 1 cycle of treatment) will be reviewed. We estimate that 50 patients could fit the criteria above, since the drug started to be prescribed in the Dermatology Clinic. Clinical information regarding diagnosis, stage, prior treatment received, and therapeutic response will be recorded. Blood parameters such as cell blood count, calcium, magnesium, potassium, and albumin at baseline and after treatment with romidepsin will be reviewed, and recorded if abnormalities are detected. Electrocardiogram changes will also be checked and recorded. All the information will be gathered in an excel spreadsheet in order to perform a descriptive analysis. We aim to assess the use of romidepsin as maintenance therapy and assess which schedule of treatment was most frequently used and associated with a better response with fewer side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients under 18 and over 89 years

• Patients with the diagnosis of CTCL that did not received romidepsin as a treatment

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cutaneous T-cell Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• Romidepsin
Received romidepsin per standard of care or through a clinical trial for more than one cycle

Locations

Country	Name	City	State
United States	Northwestern University Dermatology Department	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free disease time with maintenance therapy with romidepsin	By the time patient received the first cycle the clinical response will be assessed	4 weeks	No