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Hydroxychloroquine in isolated cutaneous mastocytosis patients or indolent systemic mastocytosis with associated skin involvement patients: proof of concept study
EU CTIS ID: 2024-518594-33-00
What this study is testing
To evaluate at 12 months the effect of hydroxychloroquine administered at a dose of 6 to 6.5mg / kg / day on mast cell activation symptoms as pruritus and / or flush moderate to severe in patients with isolated cutaneous mastocytosis and / or indolent systemic with associated skin involvement
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 18 years
- Isolated Cutaneous mastocytosis or indolent systemic mastocytosis with associated skin lesions defined according to WHO criteria (and / or international standards for cutaneous mastocytosis)
- Patient with at least one disability defined by the presence of the following symptoms assessed as moderate to severe: a. Cutaneous pruritus with score ≥ 3 on a VAS scale from 0 to 10 b. Number of flushs / week ≥ 5
- Skin KIT mutation known
- Performance scale: OMS/ECOG ≤ 1
- Woman and man of childbearing age under effective contraception during treatment with hydroxychloroquine and up to 8 months after stopping it
You likely can't join if
- Non-symptomatic mastocytosis and / or without skin involvement
- Change symptomatic treatment (including dosage) in the 4 weeks preceding the inclusion visit
- Inability to give informed consent
- Inability to undergo medical monitoring for geographical, social or psychic
- Patients with major surgery scheduled in the next two weeks screening
- Patient without health insurance
See the full eligibility criteria
- Age > 18 years
- Isolated Cutaneous mastocytosis or indolent systemic mastocytosis with associated skin lesions defined according to WHO criteria (and / or international standards for cutaneous mastocytosis)
- Patient with at least one disability defined by the presence of the following symptoms assessed as moderate to severe: a. Cutaneous pruritus with score ≥ 3 on a VAS scale from 0 to 10 b. Number of flushs / week ≥ 5
- Skin KIT mutation known
- Performance scale: OMS/ECOG ≤ 1
- Woman and man of childbearing age under effective contraception during treatment with hydroxychloroquine and up to 8 months after stopping it
- Non-symptomatic mastocytosis and / or without skin involvement
- Change symptomatic treatment (including dosage) in the 4 weeks preceding the inclusion visit
- Inability to give informed consent
- Inability to undergo medical monitoring for geographical, social or psychic
- Patients with major surgery scheduled in the next two weeks screening
- Patient without health insurance
- Pregnancy, Breastfeeding
- Vulnerable Patient, defined as: - Esperance survival < 6 months - Patient with another uncontrolled severe disease
- Patient under juridical protection
- Systemic mastocytosis with associated hematologic neoplasm (SMAHN)
- Aggressive systemic mastocytosis
- Mast cell leukemia
- History of ophthalmic disease and / or cardiac conduction disorders against-indicating the use of hydroxychloroquine
- Treatment with citalopram, escitalopram, hydroxyzine, domperidone, piperaquine due to the increased risk of ventricular rhythm disorders, especially torsades de pointes
- Specific anti-tumor treatment (chemotherapy, radiotherapy) of less than 4 weeks before inclusion.
- Concomitant specific anti-mast cell treatment
- Inclusion in another trial with an experimental therapeutic molecule
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.