Long-term Use of Romidepsin in Patients With CTCL
Condition: Cutaneous T-cell Lymphoma
MeSH terms: Lymphoma, T-Cell, Cutaneous
Study type: Observational

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.
    

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.
    

Intervention name(s): Romidepsin
Intervention type(s): Drug
Intervention description(s): Received romidepsin per standard of care or through a clinical trial for more than one cycle
Other intervention name(s): Maintenance therapy
Intervention MeSH terms: Romidepsin
Observational model: Case-Only
Time perspective: Retrospective
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.