Universitätsklinikum Freiburg | Klinik fur Dermatologie und Venerologie
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria for Main Study:
Diagnosed with one of the following advanced mastocytosis diagnoses by Eligibility Committee
Measurable disease according to modified IWG-MRT-ECNM criteria. (A subset of patients inevaluble per mIWG-MRT-ECNM will be included in the study).
ECOG (0 to 3)
Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits
Key Exclusion Criteria for Main Study:
Key Inclusion Criteria for Substudy Population:
Rollover Cohort
High-Risk Cohort
Receiving or indicated for AHN-directed therapy.
Diagnosed with one of the following pathologic diagnoses of SM-AHN:
Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits.
Key Exclusion Criteria for Substudy Population:
Primary purpose
Allocation
Interventional model
Masking
140 participants in 1 patient group
Loading...
Central trial contact
Hina Jolin, PharmD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal