NCT06327685

Avapritinib With Decitabine in Patients With SM-AHN

A Phase 1 Study of Avapritinib in Combination With Decitabine in Patients With Systemic Mastocytosis With an Associated Hematologic Neoplasm (SM-AHN)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Mastocytosis With an Associated Hematologic Neoplasm

Interventions

Type	Name	Description
DRUG	Avapritinib	Avapritinib is an oral tyrosine kinase inhibitor.
DRUG	Decitabine	Decitabine is a nucleoside metabolic inhibitor given intravenously.
COMBINATION_PRODUCT	Decitabine/Cedazuridine	Decitabine/Cedazuridine is a combination medicine given orally.

Timeline

• Start date: 2024-03-13
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2024-03-25
• Last updated: 2026-04-01

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study