A Phase 1 Study of Avapritinib in Combination With Decitabine in Patients With Systemic Mastocytosis With an Associated Hematologic Neoplasm (SM-AHN)
H. Lee Moffitt Cancer Center and Research Institute
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of SM-AHN defined by World Health Organization 2022 criteria. * ECOG 0-3 * Ability to understand and the willingness to sign a written informed consent. * Ability to adhere to study visit schedule and other protocol requirements. * Willing to receive blood products as deemed clinically necessary. * Adequate organ and marrow function as defined by the protocol. * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * For participants with evidence o…
Interventions
- DrugAvapritinib
Avapritinib is an oral tyrosine kinase inhibitor.
- DrugDecitabine
Decitabine is a nucleoside metabolic inhibitor given intravenously.
- Combination ProductDecitabine/Cedazuridine
Decitabine/Cedazuridine is a combination medicine given orally.
Locations (7)
- Mayo Clinic - ArizonaPhoenix, Arizona
- Stanford University Medical CenterPalo Alto, California
- Moffitt Cancer CenterTampa, Florida
- Dana-Farber Cancer InstituteBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan
- Memorial Sloan Kettering Cancer CenterNew York, New York