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NCT06327685 · ClinicalTrials.gov registry record · Phase 1
Avapritinib With Decitabine in Patients With SM-AHN
A Phase 1 study of Systemic Mastocytosis With an Associated Hematologic Neoplasm, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 7
- Study locations
NCT06327685 is a Phase 1 study of Systemic Mastocytosis With an Associated Hematologic Neoplasm that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 34 participants. The trial reports 7 study locations across 7 states.
The verdict
NCT06327685, a Phase 1 study of Systemic Mastocytosis With an Associated Hematologic Neoplasm, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 7
- Study locations
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 Studied
Interventions
- DRUG Decitabine
- DRUG Avapritinib
- COMBINATION_PRODUCT Decitabine/Cedazuridine
Study Locations (7)
Arizona
- Mayo Clinic - Arizona - Phoenix
California
- Stanford University Medical Center - Palo Alto
Florida
- Moffitt Cancer Center - Tampa
Massachusetts
- Dana-Farber Cancer Institute - Boston
Michigan
- University of Michigan - Ann Arbor
New York
- Memorial Sloan Kettering Cancer Center - New York
Utah
- University of Utah Health - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2024-03-13 |
| Est. Completion | 2027-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06327685
The ClinicalTrials.gov registry entry for NCT06327685 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Systemic Mastocytosis With an Associated Hematologic Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Decitabine is the first listed.
NCT06327685 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Arizona, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06327685 about?
NCT06327685 is a clinical study titled "Avapritinib With Decitabine in Patients With SM-AHN". 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 co...
What is the current status of trial NCT06327685?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2024-03-13. Estimated completion is 2027-03.
What conditions does trial NCT06327685 study?
This clinical trial studies the following conditions: Systemic Mastocytosis With an Associated Hematologic Neoplasm.
What interventions are being tested in trial NCT06327685?
The interventions under investigation include: Decitabine (DRUG), Avapritinib (DRUG), Decitabine/Cedazuridine (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06327685?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06327685 being conducted?
This trial has 7 study locations across Arizona, California, Florida, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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