NCT05084872

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

Hydroxychloroquine in Isolated Cutaneous Mastocytosis Patients or Indolent Systemic Mastocytosis With Associated Skin Involvement Patients: Proof of Concept Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Mastocytosis is an orphan disease related to the accumulation and / or the proliferation of abnormal mast cells in different tissues. In adults, a classic distinction is made between isolated cutaneous forms (10 to 15%) and systemic forms (85 to 90%). 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.

Conditions

• Mastocytosis

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Patients will be treated by hydroxychloroquine at a dose of 6 to 6.5mg/kg/day during 12 month

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2021-10-20
• Last updated: 2021-10-20

Locations

1 site across 1 country: France