- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02296398
Long-term Use of Romidepsin in Patients With CTCL
March 10, 2016 updated by: Joan Guitart, Northwestern University
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
47
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Dermatology department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 87 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Romidepsin therapy
Patients who received romidepsin per standard of care practice or included in other clinical trials (when receiving romidepsin therapy).
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Received romidepsin per standard of care or through a clinical trial for more than one cycle
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Free disease time with maintenance therapy with romidepsin
Time Frame: 4 weeks
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By the time patient received the first cycle the clinical response will be assessed
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joan Guitart, MD, Northwestern Univeristy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
October 2, 2014
First Submitted That Met QC Criteria
November 17, 2014
First Posted (Estimate)
November 20, 2014
Study Record Updates
Last Update Posted (Estimate)
March 11, 2016
Last Update Submitted That Met QC Criteria
March 10, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU95649
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cutaneous T-cell Lymphoma
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University of WashingtonNational Cancer Institute (NCI)TerminatedCutaneous T-cell Lymphoma Stage I | Cutaneous T-cell Lymphoma Stage II | Cutaneous T-cell Lymphoma Stage III | Cutaneous T-cell Lymphoma Stage IVUnited States
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Kyowa Kirin, Inc.Active, not recruitingCutaneous T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma, RelapsedUnited States, United Kingdom, Spain, France, Italy
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