Long-term Use of Romidepsin in Patients With CTCL

NCT02296398 | Completed

• 1 other identifier: STU95649
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cutaneous T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Free disease time with maintenance therapy with romidepsin

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

  4 weeks

Study Arms (1)

Romidepsin therapy

Patients who received romidepsin per standard of care practice or included in other clinical trials (when receiving romidepsin therapy).

Drug: Romidepsin

Interventions

Romidepsin DRUG

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

Also known as: Maintenance therapy

Romidepsin therapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medical records of patients with a diagnosis of cutaneous T-cell lymphoma that have presented to the Northwestern Medical Faculty Foundation Dermatology clinic, who receive romidepsin per standard of care practice will be reviewed. Retrospective chart reviews will be conducted for data collected between January 1, 2009 (when romidepsin was initially prescribed) to May 28, 2014. The prospective portion of the study will review chart data collected between May 29, 2014 and December 31, 2014.

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Dermatology Department

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

romidepsin; Maintenance

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Joan Guitart, MD

  Northwestern Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: November 20, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 11, 2016

Record last verified: 2016-03

Locations

US (1)