Cutaneous T-cell LymphomaNCT02296398
Long-term Use of Romidepsin in Patients With CTCL
An observational study of Cutaneous T-cell Lymphoma, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cutaneous T-cell Lymphoma
- What is being tested?
- Romidepsin
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients under 18 and over 89 years
- Patients with the diagnosis of CTCL that did not received romidepsin as a treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Dermatology Department
Chicago, Illinois, 60611
About this study
Official title: 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.
Read the 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.
- Conditions
- Cutaneous T-cell Lymphoma
- Being tested
- Romidepsin
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomidepsinDrug
Also called Maintenance therapy
Received romidepsin per standard of care or through a clinical trial for more than one cycle
| Study group | Role | What they receive |
|---|---|---|
| Romidepsin therapy | Patients who received romidepsin per standard of care practice or included in other clinical trials (when receiving romidepsin therapy). Receives: Drug: Romidepsin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free disease time with maintenance therapy with romidepsin
By the time patient received the first cycle the clinical response will be assessed
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Guitart, Northwestern University
- Investigators
- Joan Guitart, MD, Principal investigator, Northwestern Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296398
- Sponsor's protocol ID
- STU95649
- Status last verified
- Mar 2016
- First submitted
- 2 Oct 2014
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Study of Long-term Use of Romidepsin in Patients
- ClinicalTrials.gov ID
- NCT02296398
- Acronym / sponsor ID
- STU95649
- Conditions
- Cutaneous T-cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Romidepsin therapy | – | Drug: RomidepsinPatients who received romidepsin per standard of care practice or included in other clinical trials (when receiving romidepsin therapy). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients under 18 and over 89 years
- Patients with the diagnosis of CTCL that did not received romidepsin as a treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RomidepsinAlso: Maintenance therapyReceived romidepsin per standard of care or through a clinical trial for more than one cycle | Drug | Romidepsin therapy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Guitart, MD principal investigator
Northwestern Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous T-cell Lymphoma, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free disease time with maintenance therapy with romidepsin (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.