Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis

PHASE3CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Indolent Systemic Mastocytosis
Interventions
DRUG

Masitinib

Masitinib 6 mg/kg/day

DRUG

Placebo

Matching placebo

OTHER

Best Supportive Care

Optimal concomitant symptomatic treatments. Includes: H1- and H2-antihistamines, proton pump inhibitors (PPI), sodium cromoglicate, antidepressants, leukotriene antagonists, interferon-alpha, 2-CdA, and corticosteroids.

Trial Locations (24)

63000

CHU Clermont Ferrand, Clermont-Ferrand

69495

CHU Lyon Sud, Pierre-Bénite

77030

MD Anderson Cancer Centre, Houston

95816

UC Davis Health System , Department of Dermatology, Sacramento

Unknown

CHU d'Amiens, Amiens

Hôpital Avicenne, Bobigny

CHU de Brest, Brest

CHU de Caen, Caen

Hôpital Claude Huriez, Lille

CHU Dupuytren, Limoges

Hôpital Ambroise Paré, Marseille

Hôpital Nord, Marseille

Hôpital Central, Nancy

CHU Hôtel Dieu, Nantes

Hôpital l'Archet II, Nice

Hôpital Necker, Paris

Hôpital Tenon, Paris

Centre Hospitalier Lyon Sud, Pierre-Bénite

CHU Milétrie, Poitiers

CHU Hôpital Sud, Rennes

CHU de Saint-Etienne, Saint-Etienne

Hôpital Purpan, Toulouse

Hôpital Bretonneau, Tours

Hôpital des Hauts Clos, Troyes

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AB Science

INDUSTRY