Long-term Assessment of Chlormethine Gel in Mycosis Fungoides
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Italiana Linfomi - ETS
About this trial
The study aims to provide comprehensive insights into the long-term therapeutic outcomes, potential adverse effects, and overall patient experience with chlormethine gel, thereby informing clinical practice and guiding future treatment strategies for mycosis fungoides.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients age ≥ 18
Histologically confirmed diagnosis of MF based on WHO Classification of Tumours, Haematolymphoid Tumours, 5th edition
Patients who are capable of understanding and willing, and able to read and write in Italian
Patients who have signed informed consent form
Disqualifiers
Patients for whom retrospective data or information on the type of therapy, duration, and clinical outcomes are not available in the center's medical records.
Refuse to sign a written informed consent.
Patients not meeting the above-mentioned inclusion criteria
Trial population
The study population consists of patients with histologically confirmed MF treated with TC gel (from September 1, 2019 to September 30, 2024) at the participating centers.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
190 Participants
are grouped into 1 trial groupGroup A: Patients who started treatment with chlormethine gel, from September 1, 2019 to September 30, 2024
Trial outcomes
Primary outcomes
1
Rate of complete remission (rate CR)
Rate of complete remission (rate CR) according to CAILS and mCAILS tools and mSWAT after 6 months from the start of treatment
Time frame
Up to 12 monthsSecondary outcomes
1
Percentage of CR and ORR (CR+PR)
Percentage after 3, 6 and 12 months from start of treatment of CR and ORR (CR+PR)
Time frame
Up to 12 months2
Nelson-Aalen estimation
Nelson-Aalen estimation from start of treatment to first attained CR
Time frame
Up to 12 months3
Kaplan-Meier estimation of Time to recurrence (TTR)
Kaplan-Meier estimation of Time to recurrence (TTR) from date of attained CR
Time frame
Up to 12 months4
Percentage of relevant toxicities over an extended use
Percentage of relevant toxicities over an extended use
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione Italiana Linfomi - ETS
Lead sponsor
RECORDATI GROUP
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: