Long-term Use of Romidepsin in Patients With CTCL
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| End Date: | August 2015 |
Retrospective and Prospective Study of Long-term Use of Romidepsin in Patients
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.
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.
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.
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.
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
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