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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: Recruiting Phase 1 study of Systemic Mastocytosis With an Associated Hematologic Neoplasm, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Recommended phase 2 dose which will be determined by evaluating all safety and efficacy data.
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 |
What NCT06327685 shows while recruiting
NCT06327685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
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 lists 7 locations in 7 states (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.
Learn More About Clinical Trials
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Where NCT06327685's enrollment target sits among peer trials
34 1274th of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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