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NCT03113643 · ClinicalTrials.gov registry record · Phase 1
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 3
- Study locations
NCT03113643: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Dana-Farber Cancer Institute.
NCT03113643 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 72 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (38% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03113643, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 3
- Study locations
Study Summary
This research study is studying a drug as a possible treatment for diagnosis of AML, BPDCN and high-risk MDS. The interventions involved in this study are: * SL-401 * Azacitidine * Venetoclax
Primary Outcome
To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of SL-401 in combination with azacitidine or in combination with azacitidine and venetoclax in this patient population and evaluate the safety of this regimen
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG SL-401
Study Locations (3)
California
- City of Hope - Duarte
Massachusetts
- Dana Farber Cancer Institute - Boston
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2017-06-26 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 1 |
What NCT03113643 shows while recruiting
NCT03113643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (38% lower).
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT03113643 reports a single indexed study location in California, Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT03113643 about?
NCT03113643 is a clinical study titled "SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)". This research study is studying a drug as a possible treatment for diagnosis of AML, BPDCN and high-risk MDS. The interventions involved in this study are: * SL-401 * Azacitidine * Venetoclax
What is the current status of trial NCT03113643?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2017-06-26. Estimated completion is 2027-05-31.
What conditions does trial NCT03113643 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Blastic Plasmacytoid Dendritic Cell Neoplasm.
What interventions are being tested in trial NCT03113643?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), SL-401 (DRUG).
Who is sponsoring clinical trial NCT03113643?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03113643 being conducted?
This trial has 3 study locations across California, Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03113643's enrollment target sits among peer trials
72 107th of 306 higher than 198 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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