Overview

Study of BLU-263 in Advanced Systemic Mastocytosis (AdvSM) and and Other KIT Altered Hematologic Malignancies

Status:
Not yet recruiting

Trial end date:
2027-11-05

Target enrollment:

Participant gender:

Summary

The goal of this clinical trial is to evaluate BLU-263 in participants with Advanced Systemic Mastocytosis (AdvSM), SM-Associated hematologic neoplasm (SM-AHN), and other hematologic malignancies. The main questions it aims to answer are: - Determine Recommended Dose of BLU-263 monotherapy for participants with AdvSM - Safety and tolerability of BLU-263 monotherapy - Efficacy of BLU-263 monotherapy in participants with AdvSM - Determine Recommended Dose of BLU-263 in combination with azacitidine in participants with AdvSM - Safety and tolerability of BLU-263 in combination with azacitidine - Efficacy of BLU-263 in combination with azacitidine in participants with AdvSM The estimated study duration for each participant will be approximately 4 years: 2 years of treatment followed by 2 years of follow-up. Participants may be required to attend monthly visits for the first six months, followed by quarterly visits for the remainder of the study.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Blueprint Medicines Corporation

Treatments:

Azacitidine