Avapritinib With Decitabine in Patients With SM-AHN
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
History of decitabine use with documented disease progression of AHN by 2006 IWG MDS response criteria while on decitabine.
History of avapritinib use with documented progression of mastocytosis while on avapritinib per m-IWG-MRT-ECNM criteria.
History of treatment with decitabine in combination with avapritinib.
Use of azacitidine within 4 weeks of first dose of study drug.
Trial design
Treatments tested in this trial
- Avapritinib
- Decitabine
- Decitabine/Cedazuridine
Treatment groups
34 Participants
are divided into 2 treatment groupsSponsors and collaborators
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Blueprint Medicines Corporation
Collaborator
Source ClinicalTrials.gov