(Apex) CGT9486 in Patients With Advanced Systemic Mastocytosis
18 Years and older, Male and Female
CGT9486-20-201 (primary)
2021-001010-10
NCI-2021-09477
Summary
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).
Eligibility
- Diagnosed with 1 of the following advanced mastocytosis diagnoses by Eligibility Committee:
- Aggressive Systemic Mastocytosis (ASM)
- Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN)
- Mast Cell Leukemia (MCL)
- Measurable disease according to modified IWG-MRT-ECNM criteria
- ECOG (0 to 3)
- Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits
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