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Long-term Use of Romidepsin in Patients With CTCL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02296398
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : March 11, 2016
Information provided by (Responsible Party):
Joan Guitart, Northwestern University

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.

Condition or disease Intervention/treatment
Cutaneous T-cell Lymphoma Drug: Romidepsin

Detailed 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.

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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective and Prospective Study of Long-term Use of Romidepsin in Patients
Study Start Date : January 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Romidepsin

Group/Cohort Intervention/treatment
Romidepsin therapy
Patients who received romidepsin per standard of care practice or included in other clinical trials (when receiving romidepsin therapy).
Drug: Romidepsin
Received romidepsin per standard of care or through a clinical trial for more than one cycle
Other Name: Maintenance therapy

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02296398

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United States, Illinois
Northwestern University Dermatology Department
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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Principal Investigator: Joan Guitart, MD Northwestern Univeristy

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Responsible Party: Joan Guitart, MD, Northwestern University Identifier: NCT02296398    
Other Study ID Numbers: STU95649
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents