protocolSection identificationModule nctId: NCT06327685, orgStudyIdInfo id: MCC-22318, briefTitle: Avapritinib With Decitabine in Patients With SM-AHN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: H. Lee Moffitt Cancer Center and Research Institute, class: OTHER, collaborators name: Blueprint Medicines Corporation, descriptionModule briefSummary: Systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) is a challenging disease to treat. Targeted KIT inhibitors have been approved for this indication based on their ability to control the mastocytosis portion of the disease, but patients frequently experience progression of the concomitant myeloid malignancy (i.e. the AHN). Using a combination approach to treat both aspects of the disease has the potential to provide enhanced disease control; however, overlapping toxicity is a concern. In this study, investigators aim to study the safety and tolerability of combined avapritinib and decitabine for the treatment of SM-AHN., conditionsModule conditions: Systemic Mastocytosis With an Associated Hematologic Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Avapritinib, interventions name: Decitabine, interventions name: Decitabine/Cedazuridine, outcomesModule primaryOutcomes measure: Recommended phase 2 dose (RP2D), secondaryOutcomes measure: Systemic mastocytosis overall response rate (ORR), secondaryOutcomes measure: Overall Responsive Rate, secondaryOutcomes measure: Incidence and frequency of AEs and changes in vital signs, ECGs, and laboratory tests, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic - Arizona, status: NOT_YET_RECRUITING, city: Phoenix, state: Arizona, zip: 85054, country: United States, contacts name: Cecilia Arana Yi, MD, role: CONTACT, contacts name: Cecilia Arana Yi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Stanford University Medical Center, status: NOT_YET_RECRUITING, city: Palo Alto, state: California, zip: 94305, country: United States, contacts name: Jason Gotlib, MD, role: CONTACT, contacts name: Jason Gotlib, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.44188, lon: -122.14302, locations facility: Moffitt Cancer Center, status: RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Caroline Wagstaff, role: CONTACT, phone: 813-745-5197, email: Caroline.Wagstaff@moffitt.org, contacts name: Andrew Kuykendall, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Onyee Chan, role: SUB_INVESTIGATOR, contacts name: Rami Komrokji, role: SUB_INVESTIGATOR, contacts name: Timothy Kubal, role: SUB_INVESTIGATOR, contacts name: Jeffrey Lancet, role: SUB_INVESTIGATOR, contacts name: Eric Padron, role: SUB_INVESTIGATOR, contacts name: David Sallman, role: SUB_INVESTIGATOR, contacts name: Alison Walker, role: SUB_INVESTIGATOR, contacts name: Seongseok Yun, role: SUB_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Dana-Farber Cancer Institute, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Daniel DeAngelo, MD, PhD, role: CONTACT, contacts name: Daniel DeAngelo, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University of Michigan, status: NOT_YET_RECRUITING, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Kristen Pettit, MD, role: CONTACT, contacts name: Kristen Pettit, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, locations facility: Memorial Sloan Kettering Cancer Center, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Raajit Rampal, MD, PhD, role: CONTACT, contacts name: Raajit Rampal, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of Utah Health, status: NOT_YET_RECRUITING, city: Salt Lake City, state: Utah, zip: 84132, country: United States, contacts name: Tsewang Tashi, MD, role: CONTACT, contacts name: Tsewang Tashi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False