drugset / Trial / NCT06327685
Avapritinib With Decitabine in Patients With SM-AHN
Phase 1
Recruiting
34 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Blueprint Medicines Corporation · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2024-03-13
- Primary completion
- 2027-03
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avapritinib | Small molecule | 50 mg | Oral |
| Subject | Avapritinib | Small molecule | 100 mg | Oral |
| Subject | Avapritinib | Small molecule | 150 mg | Oral |
| Subject | Avapritinib | Small molecule | 200 mg | Oral |
| Subject | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Decitabine/Cedazuridine | Unknown | 35 mg | Oral |
| Subject | Decitabine/Cedazuridine | Unknown | 100 mg | Oral |