nctId: NCT06327685 id: MCC-22318 briefTitle: Avapritinib With Decitabine in Patients With SM-AHN overallStatus: RECRUITING date: 2024-03-13 date: 2027-03 date: 2027-03 date: 2024-03-25 date: 2024-04-09 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER name: Blueprint Medicines Corporation 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. conditions: Systemic Mastocytosis With an Associated Hematologic Neoplasm studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Avapritinib name: Decitabine name: Decitabine/Cedazuridine measure: Recommended phase 2 dose (RP2D) measure: Systemic mastocytosis overall response rate (ORR) measure: Overall Responsive Rate measure: Incidence and frequency of AEs and changes in vital signs, ECGs, and laboratory tests sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic - Arizona status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85054 country: United States name: Cecilia Arana Yi, MD role: CONTACT name: Cecilia Arana Yi, MD role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Stanford University Medical Center status: NOT_YET_RECRUITING city: Palo Alto state: California zip: 94305 country: United States name: Jason Gotlib, MD role: CONTACT name: Jason Gotlib, MD role: PRINCIPAL_INVESTIGATOR lat: 37.44188 lon: -122.14302 facility: Moffitt Cancer Center status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Caroline Wagstaff role: CONTACT phone: 813-745-5197 email: Caroline.Wagstaff@moffitt.org name: Andrew Kuykendall, MD role: PRINCIPAL_INVESTIGATOR name: Onyee Chan role: SUB_INVESTIGATOR name: Rami Komrokji role: SUB_INVESTIGATOR name: Timothy Kubal role: SUB_INVESTIGATOR name: Jeffrey Lancet role: SUB_INVESTIGATOR name: Eric Padron role: SUB_INVESTIGATOR name: David Sallman role: SUB_INVESTIGATOR name: Alison Walker role: SUB_INVESTIGATOR name: Seongseok Yun role: SUB_INVESTIGATOR lat: 27.94752 lon: -82.45843 facility: Dana-Farber Cancer Institute status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Daniel DeAngelo, MD, PhD role: CONTACT name: Daniel DeAngelo, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: University of Michigan status: NOT_YET_RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Kristen Pettit, MD role: CONTACT name: Kristen Pettit, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: Memorial Sloan Kettering Cancer Center status: NOT_YET_RECRUITING city: New York state: New York zip: 10065 country: United States name: Raajit Rampal, MD, PhD role: CONTACT name: Raajit Rampal, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: University of Utah Health status: NOT_YET_RECRUITING city: Salt Lake City state: Utah zip: 84132 country: United States name: Tsewang Tashi, MD role: CONTACT name: Tsewang Tashi, MD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False