Mechlorethamine Induced Contact Dermatitis Avoidance Study
United States28 participantsStarted 2017-12-13
Plain-language summary
This is a two-arm, open-label study that aims to compare the incidence and severity of the most common adverse reactions, particularly contact dermatitis, when Valchlor is used alone or in conjunction with triamcinolone ointment 0.1% in early stage MF subjects (Stage IA and IB) for a period of 4 months.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be eligible to receive Valchlor therapy.
* Be at least of 18 years of age and ability to give informed consent
* Have stage IA or IB CTCL
* Subjects with histologic variants of Mycosis Fungoides such as folliculotropic, granulomatous slack skin, syringotropic MF, or large cell transformation ARE eligible.
* A skin biopsy within the last 60 days before start of treatment. In cases with equivocal histological features, the diagnosis may be confirmed with clinicopathologic and/or genetic testing consistent with the National Comprehensive Cancer Network guidelines for Mycosis Fungoides. If sufficient tissue is not available to perform genetic testing, a new biopsy will be performed even if the subject has had a biopsy within 60 days of start of treatment.
* Females of child bearing potential must agree to use two highly effective methods of contraception (strongly recommended that one of the two forms of contraception be non-hormonal such as condom plus spermicide, condom plus diaphragm with spermicide, or have a vasectomized partner) or use an intrauterine device until 30 days after the last day of drug administration. Perimenopausal women must be amenorrhoeic for at least 12 months to be considered of nonchildbearing potential.
* Males with female partners of child bearing potential must agree to sexual abstinence or use two reliable forms of effective contraception simultaneously (strongly recommended that one of the two forms should be non-hormonal as d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was specifically looking at reducing moderate to severe skin reactions from mechlorethamine — since it's already completed, can you tell me what the results showed and whether that changes how you'd recommend I use this treatment for my mycosis fungoides?
2Mechlorethamine gel is applied directly to the skin, and contact dermatitis seems to be a significant enough side effect that a whole Phase 2 study was built around it — how common and how severe is this reaction in practice, and what would we do if I developed it?
3Since this trial focused on patients with several different subtypes, including folliculotropic and transformed mycosis fungoides, does my specific subtype affect how likely I am to experience this skin reaction or how well mechlorethamine tends to work?
4Given that this was a Phase 2 trial measuring a safety and tolerability issue rather than comparing mechlorethamine to other treatments, are there alternative topical or systemic therapies for my stage of cutaneous T-cell lymphoma that might carry a lower risk of this kind of skin reaction?
5If mechlorethamine gel is something you're considering for me, are there strategies — like the approach this trial may have been testing — that your practice already uses to help prevent or manage contact dermatitis before it becomes a serious problem?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring
Timeframe: 4 months
Trial details
NCT IDNCT03380026
SponsorRochester Skin Lymphoma Medical Group, PLLC