Blood cancer affecting the skin
Conditions
Interventions
Chlormethine gel 0.016%, thrice weekly the first 4 weeks followed by once daily
for the next 12 weeks
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy volunteers must meet all of the following inclusion criteria: 1. Signed informed consent prior to any study-mandated procedure; 2. Male or female subjects, 18 to 75 years of age, inclusive at screening; in general, stable good health as per judgement of the investigator based upon the results of a medical history, physical examination, vital signs, ECG and laboratory assessments performed at screening. Repeated laboratory testing may be performed at the discretion of the clinical investigators; 3. Body mass index (BMI) >= 18.0 and = 18.0 and = 18.0 and = 18.0 and = 6cm. 5. Confirmed MF-diagnosis (stage 1a/1b) by histology (or clinico-histopathological correlation) within the last 10 years. 6. Willing and able to washout any topical treatment for MF (at least 2 weeks) and any systemic treatment for MF (at least 4 weeks) prior to Day 1, resulting in a washout of 8 weeks for topical treatment and 10 weeks for disease-related systemic treatment prior to the first dosing day (day 43). 7. No previous use of CL gel (Ledaga) in the past two years. 8. Subject is willing and able to washout (topical and oral) antibiotic therapy for 14 days prior to Day 1. 9. Subject is willing to refrain from extensively washing (including bathing, swimming, showering and excessive sweating) the skin 6 hours before every study visit day and up to 2 hours after application of the treatment
Exclusion criteria
Exclusion criteria: Eligible healthy volunteers must meet none of the following exclusion criteria at screening: 1. History of immunological abnormality (e.g., immune suppression) that may interfere with study objectives, in the opinion of the investigator. 2. The use of systemic antibiotic therapy for >2 months the past 12 months. 3. The use of any oral/systemic medication (e.g. immunomodulatory, immunosuppressive) within 28 days prior to Day 1, if the investigator judges that it may interfere with the study objectives. 4. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV ab), or human immunodeficiency virus antibody (HIV ab) at screening; 5. Participation in an investigational drug study within 3 months prior to screening or more than 4 times a year. 6. Loss or donation of blood over 500mL within three months prior to screening. 7. History of alcohol consumption exceeding 5 standard drinks per day on average within 3 months of screening. Alcohol consumption will be prohibited from at least 24 hours preceding each study visit. 8. Positive urine test for drugs or history of abuse at screening or pre-dose. Urine drug test may be repeated at the discretion of the investigator; 9. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding; 10. Any other known factor, condition, or disease that might interfere with study conduct or interpretation. Eligible MF-patients must meet none of the abovementioned and following exclusion criteria at screening: 1. Have any current relevant skin infections/disease in the treatment area other than the observational disease (mycosis fungoides), inclusively, but not limited to atopic dermatitis, psoriasis vulgaris, dermatomycosis and other skin malignancies. 2. Having received treatments for MF or any other disease within the following intervals prior to the start of the study (The use of topical emollients is allowed during the study. For target lesions it is allowed up to 24h before every study visit day): a.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study will monitor the changes over time of selected biomarkers. For clinical applicability, a biomarker should be comparable over time and distinctive within the selected study groups (healthy/MF-patients and lesional/non-lesional). Due to the exploratory nature of this study, a major primary endpoint is missing. Furthermore, based on developments in analysis or based on results, additional analysis on the taken samples could be added in the future. The following general endpoints have been defined, with the groups defined as early-stage MF-patients and healthy volunteers. * Comparable biomarker measurements (as described below under endpoints) over time and within groups for the observational part of the study * Difference in non-invasive and/or invasive biomarker measurements between different groups (that ultimately could lead to improved disease classification) * MF subgroups (responders vs non-responders): change in any of the invasive and/or non-invasive biomarkers after 16 weeks of treatment with CL gel compared to measurements of untreated/non-lesional skin | — |
Secondary
| Measure | Time frame |
|---|---|
| N.v.t. | — |
Countries
Netherlands
Outcome results
None listed