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).

View Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT04996875

Recruitment Status:

Recruiting

Sponsor:

Cogent Biosciences, Inc.

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There are 38 Locations for this study

See Locations Near You

University of Alabama at Birmingham (UAB) Hospital
Birmingham Alabama, 35233, United States
Mayo Clinic Arizona
Phoenix Arizona, 85054, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
UCLA Medical Center
Los Angeles California, 90095, United States
Stanford Cancer Institute
Stanford California, 94305, United States
Galiz Research
Hialeah Florida, 33016, United States
Winship Cancer Institute - Emory University
Atlanta Georgia, 30322, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Columbia University Irving Medical Center
New York New York, 10032, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44106, United States
MUSC Health University Medical Center
Charleston South Carolina, 29425, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Huntsman Cancer Institute - University of Utah Health
Salt Lake City Utah, 84112, United States
Nepean Hospital
Kingswood New South Wales, 2747, Australia
Gold Coast University Hospital
Southport Queensland, 4215, Australia
Peter MacCallum Cancer Centre
Melbourne N. Victoria, 3051, Australia
AKH Wien, Universitatsklinikum
Vienna , 1090, Austria
CHU de Liege
Liège , 4000, Belgium
University of Alberta Hospital
Edmonton Alberta, T6G 2, Canada
St. Michael's Hospital - Unity Health Toronto
Toronto Ontario, M5B 1, Canada
Necker-Enfants Malades Hospital
Paris , 75015, France
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers , 86000, France
Centre Hospitalier Universitaire (CHU) de Toulouse
Toulouse , 31300, France
University Hospital Aachen
Aachen , 52074, Germany
Universitätsklinikum Freiburg
Freiburg , 79104, Germany
Universitätsklinikum Mannheim
Mannheim , 68167, Germany
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna , 40138, Italy
Azienda Ospidaleira Universitaria Integrata Verona
Verona , 37124, Italy
University Medical Center Groningen
Groningen , 9713, Netherlands
Oslo University Hospital
Oslo , 0450, Norway
Hospital Universitario Vall d'Hebron
Barcelona , 08740, Spain
Institut Català d'Oncologia - Hospital Duran i Reynals
Barcelona , 08908, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Universitätsspital Basel
Basel , 4031, Switzerland
Leeds Teaching Hospitals NHS Trust
Leeds , LS9 7, United Kingdom
University College London Hospital - NHS Foundation Trust
London , NW1 2, United Kingdom
Guy's Hospital - NHS Foundation Trust
London , SE1 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT04996875

Recruitment Status:

Recruiting

Sponsor:


Cogent Biosciences, Inc.

How clear is this clinincal trial information?

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