UnknownPhase 2/3

Hydroxychloroquine in Isolated Cutaneous Mastocytosis Patients or Indolent Systemic Mastocytosis With Associated Skin Involvement Patients

France30 participantsStarted 2021-10

Plain-language summary

The treatment of systemic mastocytosis has two main axes: * Control of mast cell activation symptoms and * The control of proliferation (accumulation) of mast cells. There is no standard treatment and no treatment has a marketing authorization for the treatment of monoclonal indolent mastocytosis.

Who can participate

Age range18 Years

SexALL

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Inclusion 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:
✓. Cutaneous pruritus with score ≥ 5 on a VAS scale from 0 to 10
✓. Number of flushes / week ≥ 7
✓. Skin KIT mutation known
✓. Performance scale: OMS/ECOG ≤ 1
✓. Woman and man of childbearing age\* under effective contraception during all the treatment by hydroxychloroquine, until 8 months after its cessation

What they're measuring

Change of mast cell activation symptoms

Timeframe: 12 month

Change of mast cell activation symptoms

Timeframe: 12 month

Trial details

NCT IDNCT05084872

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01

Contact for this trial

Maella Severino-Freire, MD

05 67 77 81 41 severino-freire.m@chu-toulouse.fr

View on ClinicalTrials.gov More Mastocytosis trials