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

Stopped early · Phase 1

Conditions studied: Advanced Systemic Mastocytosis

In brief

The goal of this clinical trial is to evaluate elenestinib (BLU-263) in participants with Advanced Systemic Mastocytosis (AdvSM), SM with an associated hematologic neoplasm (SM-AHN), and other hematologic malignancies. The main questions it aims to answer are: * Determine Recommended Dose of elenestinib (BLU-263) monotherapy for participants with AdvSM * Safety and tolerability of elenestinib (BLU-263) monotherapy * Efficacy of elenestinib (BLU-263) monotherapy in participants with AdvSM * Determine Recommended Dose of elenestinib (BLU-263) in combination with azacitidine in participants with AdvSM * Safety and tolerability of elenestinib (BLU-263) in combination with azacitidine * Efficacy of elenestinib (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.

Key facts

Study ID

NCT05609942

Run by

Blueprint Medicines Corporation

People needed

9

Starts

2023-09-25

Expected to finish

2025-03-10

Last updated by the study team

2025-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Stanford Cancer Institute — Palo Alto, California, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Antwerp University Hospital — Edegem, Belgium
• University Hospital Ghent — Ghent, Belgium
• CHU Caen - Institut d'Hematologie de Basse Normandie — Caen, France
• University Medical Centre Mannheim — Mannheim, Germany
• Maastricht University Medical Center — Maastricht, Netherlands
• Oslo University Hospital — Oslo, Norway
• Instituto de Estudios de Mastocitosis de Castilla La Mancha (CLMast) — Toledo, Spain

Full record on ClinicalTrials.gov

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