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 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.

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Key information

Conditions

Cutaneous T-Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University Dermatology Department

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Romidepsin

Drug

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

Other names: Maintenance therapy

Primary outcomes

Free disease time with maintenance therapy with romidepsin

Time frame: 4 weeks

By the time patient received the first cycle the clinical response will be assessed

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Nov 20, 2014
Registry last updated: Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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