Study Overview
This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
Description
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).
Official Title
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
Quick Facts
Study Start:2021-11-09
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Contacts and Locations
Study Locations (Sites)
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
Collaborators and Investigators
Sponsor: Cogent Biosciences, Inc.
- Rachael Easton, MD, Ph.D., STUDY_DIRECTOR, Cogent Biosciences, Inc.
Study Record Dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
Study Start Date2021-11-09
Study Completion Date2026-07
Study Record Updates
Study Start Date2021-11-09
Study Completion Date2026-07
Terms related to this study
Keywords Provided by Researchers
- Mastocytosis
- Systemic Mastocytosis
- Advanced Mastocytosis
- Aggressive Mastocytosis
- Hematologic Neoplasms
- Mast Cell
- Mast Cell Leukemia
- Soft Tissue Neoplasms
- Neoplasms by site
- Skin Diseases
- Immune Complex Diseases
- Immune System Diseases
- Hypersensitivity
- Hematologic Diseases
- Leukemia
- Myeloid Leukemia
- Acute Myeloid Leukemia
- SM with Associated Hematologic Neoplasm
- AdvSM
- ASM
- SM-AHN
- MCL
- Neoplasm
- D816V
- KIT D816V
- AML
- bezuclastinib
- CGT9486
- CGT
- PLX
- Connective Tissue Neoplasms
- Urticaria Pigmentosa
- High-risk myelodysplastic syndrome
- Chronic myelomonocytic leukemia
- Myeloproliferative neoplasm
- High-risk myeloid neoplasm
- High-risk MDS
- MPN
- High-risk MPN
- Accelerated phase MPN
- CMML
Additional Relevant MeSH Terms
- Advanced Systemic Mastocytosis (AdvSM)
- SM with an Associated Hematologic Neoplasm (SM-AHN)
- Mast Cell Leukemia (MCL)
- Aggressive Systemic Mastocytosis (ASM)