SL-401 with Azacitidine or Azacitidine/Venetoclax for AML, MDS, or BPDCN

This study is testing SL-401 in combination with azacitidine, or azacitidine and venetoclax, for people with acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (MDS), or blastic plasmacytoid dendritic cell neoplasm (BPDCN). SL-401 works by targeting leukemia cells and potentially slowing the growth of cancer stem cells. The main goal is to find the safest and highest dose of SL-401 when given with these other drugs. To join, you must be at least 18 years old and have one of these conditions with CD123 / IL3RA expression on your cancer cells. This is a Phase 1 study, meaning it focuses on safety and finding the right dose. The study plans to enroll 72 participants.

Study design
This is a Phase 1 interventional study, which means it tests the safety and appropriate dose of the treatments. It plans to enroll 72 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The Maximum Tolerated Dose will be measured at 2 years.

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NCT03113643

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Dana-Farber Cancer Institute
~72 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:AzacitidineSL-401Venetoclax

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose
Measured over 2 years
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Blastic Plasmacytoid Dendritic Cell Neoplasm
3 sites across 3 states
California1
Massachusetts1
Texas1
  • Andrew Lane, MD, PhD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

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  • Maximum Tolerated Dose2 years

    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