Clinical trials with new drugs
APEX
Patient target group: Advanced systemic mastocytosis
Study details: Study to test the efficacy and safety of the tyrosine kinase inhibitor bezuclastinib in patients with advanced systemic mastocytosis
Name of study: A Phase 2, Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis (APEX)
Sponsor: Cogent
Clinical center: University Hospital Basel, current status: No more patients needed for the study (recruitment completed)
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HARBOR
Patient target group: Indolent systemic mastocytosis
Study details: Study to evaluate the efficacy and safety of the tyrosine kinase inhibitor elenestinib (compared to placebo) in patients with indolent systemic mastocytosis
Name of study: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study of BLU-26 in Indolent Systemic Mastocytosis (HARBOR)
Sponsor: Blueprint
Clinical center:
- University Hospital Basel, current status: No new patients can be included in the study until 2024 (recruitment paused)
- Luzerner Kantonsspital, current status: no patients can be included in the study until 2024 (recruitment paused)
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PIONEER
Patient target group: Indolent and smoldering systemic mastocytosis
Study details: Study to test the efficacy and safety of the tyrosine kinase inhibitor avapritinib in patients with indolent systemic mastocytosis
Name of study: A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis with Symptoms Inadequately Controlled with Standard Therapy (PIONEER)
Sponsor: Blueprint
Clinical center:
- University Hospital Basel, current status: No new patients can be included in the study until 2024 (recruitment paused)
- Luzerner Kantonsspital, current status: no patients can be included in the study until 2024 (recruitment paused)​​
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SUMMIT
Patient target group: Indolent systemic mastocytosis
Study details: Study to test the efficacy and safety of the tyrosine kinase inhibitor bezuclastinib (compared to placebo) in patients with indolent systemic mastocytosis
Name of study: A Multi-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of the Safety and Efficacy of CGT9486 in Subjects with Nonadvanced Systemic Mastocytosis (SUMMIT)
Sponsor: Cogent
Clinical center: University Hospital Basel, current status: no more patients needed for the study (recruitment completed)
Registries / Observational Studies
ECNM Registry
Patient target group: All forms of mastocytosis
Study details: International registry for patients with mastocytosis
Name of study: Data Registry of the European Competence Network on Mastocytosis (ECNM)
Sponsor: Prof. Dr. Wolfang Sperr and Prof. Dr. Peter Valent, Medical University of Vienna
Clinical center:
- Kantonsspital Aarau, current status: patients wanted (recruitment open)
- University Hospital Basel, current status: patients wanted (recruitment open)
- Luzerner Kantonsspital, current status: patients wanted (recruitment open)
Biobank
Biobank Allergy and Immunity, University Hospital Basel
Patient target group: All forms of mastocytosis
Study details: Collection of biological material (blood, tissue samples) of patients with mastocytosis to investigate basic disease mechanisms
Sponsor: Prof. Dr. Karin Hartmann, University Hospital Basel and University of Basel
Status: Patients wanted (recruitment open)