Acute Myeloid Leukemia Clinical Trial
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
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 Criteria
Key Inclusion Criteria for Main Study:
Diagnosed with one 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. (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:
Persistent toxicity from previous therapy for AdvSM that has not resolved to ≤ Grade 1
Associated hematologic neoplasm requiring immediate antineoplastic therapy
Clinically significant cardiac disease
Known positivity for the FIP1L1 PDGFRA fusion. Patients with eosinophilia without detectable KIT D816V mutation must demonstrate lack of PDGFRA fusion mutation prior to enrollment
Seropositive for human immunodeficiency virus (HIV) 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody
History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study
Diagnosed with or treated for malignancy other than the disease under study within the prior 3 years before enrollment
Received any cytoreductive therapy or any investigational agent less than 14 days, and for cladribine, interferon alpha, pegylated interferon, and any antibody therapy less than 28 days, before screening bone marrow biopsy
Received hematopoietic growth factor support within 14 days before the first dose of study drug
Received strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives, whichever is longer, before the first dose of study drug
Need for treatment with high dose steroids
Key Inclusion Criteria for Substudy Population:
Rollover Cohort
Demonstrate AHN progression requiring immediate AHN-directed therapy while receiving bezuclastinib
Demonstrated clinical benefit from bezuclastinib therapy
Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits
High-Risk Cohort
Receiving or indicated for AHN-directed therapy.
Diagnosed with one of the following pathologic diagnoses of SM-AHN:
Myelodysplastic syndrome (MDS) that is high- or very high-risk
Accelerated phase myeloproliferative neoplasm (MPN)
MDS with excessive blasts in bone marrow or peripheral blood
Chronic myelomonocytic leukemia-2 (CMML-2)
Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits.
Key Exclusion Criteria for Substudy Population:
Diagnosis of Philadelphia chromosome-positive malignancy
Diagnosis of acute myeloid leukemia (AML)
Appropriate for allogenic hematopoietic stem cell transplantation
Any contraindication to selected concomitant therapy
Rollover Cohort: Have not demonstrated acceptable tolerability of previous bezuclastinib therapy
High-Risk Cohort: Previously treated with investigational therapy for AdvSM
High-Risk Cohort: Previously treated with cytoreductive therapy and discontinued due to treatment-related toxicity
High-Risk Cohort: Received any cytoreductive therapy or any investigational agent less than 14 days, and for cladribine, interferon alpha, pegylated interferon, and any antibody therapy less than 28 days, before screening or archival bone marrow biopsy
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There are 35 Locations for this study
Birmingham Alabama, 35233, United States
Phoenix Arizona, 85054, United States
Duarte California, 91010, United States
Los Angeles California, 90095, United States
Stanford California, 94305, United States
Hialeah Florida, 33016, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60612, United States
Boston Massachusetts, 02215, United States
New York New York, 10032, United States
Cleveland Ohio, 44106, United States
Charleston South Carolina, 29425, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Kingswood New South Wales, 2747, Australia
Southport Queensland, 4215, Australia
Melbourne N. Victoria, 3051, Australia
Vienna , 1090, Austria
Liège , 4000, Belgium
Edmonton Alberta, T6G 2, Canada
Toronto Ontario, M5B 1, Canada
Poitiers , 86000, France
Toulouse , 31300, France
Aachen , 52074, Germany
Freiburg , 79104, Germany
Mannheim , 68167, Germany
Bologna , 40138, Italy
Groningen , 9713, Netherlands
Oslo , 0450, Norway
Barcelona , 08740, Spain
Barcelona , 08908, Spain
Madrid , 28034, Spain
Basel , 4031, Switzerland
London , NW1 2, United Kingdom
London , SE1 9, United Kingdom
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