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Avapritinib With Decitabine in Patients With SM-AHN

NCT06327685 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-04-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Blueprint Medicines Corporation

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Andrew Kuykendall, MD · Moffitt Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-13
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06327685 on ClinicalTrials.gov