deltatrials
Recruiting PHASE1 INTERVENTIONAL 2-arm 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)

Phase 1 Study of SL-401 in Combination With Azacitidine and Venetoclax in Relapsed/Refractory Acute Myeloid Leukemia (AML) and in Treatment-Naive Subjects With AML Not Eligible for Standard Induction and in Subjects With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) or SL-401 in Combination With Azacitidine in Subjects With High-Risk Myelodysplastic Syndrome (MDS)

Sponsor: Dana-Farber Cancer Institute

Conditions Acute Myeloid Leukemia Blastic Plasmacytoid Dendritic Cell Neoplasm Myelodysplastic Syndrome
Interventions Azacitidine SL-401 Venetoclax
Updated 18 times since 2017 Last updated: Nov 3, 2025 Started: Jun 26, 2017 Primary completion: May 31, 2026 Completion: May 31, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Acute Myeloid Leukemia and Blastic Plasmacytoid Dendritic Cell Neoplasm and is currently actively recruiting participants. Dana-Farber Cancer Institute leads this study, which shows 18 recorded versions since 2017 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~May 2017 – ~Jul 2017 · 2 months · monthly snapshot~Jul 2017 – ~Oct 2017 · 3 months · monthly snapshot~Oct 2017 – ~Feb 2018 · 4 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshot~Feb 2019 – ~Oct 2019 · 8 months · monthly snapshot~Oct 2019 – ~May 2020 · 7 months · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Jun 2021 · 4 months · monthly snapshot~Jun 2021 – ~Dec 2021 · 6 months · monthly snapshot~Dec 2021 – ~Jul 2022 · 7 months · monthly snapshot~Jul 2022 – ~Jul 2023 · 12 months · monthly snapshot~Jul 2023 – ~Jul 2024 · 12 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jul 2025 · 10 months · monthly snapshot~Jul 2025 – ~Dec 2025 · 5 months · monthly snapshot~Dec 2025 – present · 7 months · monthly snapshot

Change History

18 versions recorded

  1. Dec 2025 — Present [monthly]

    Recruiting PHASE1

  2. Jul 2025 — Dec 2025 [monthly]

    Recruiting PHASE1

  3. Sep 2024 — Jul 2025 [monthly]

    Recruiting PHASE1

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1

  5. Jul 2023 — Jul 2024 [monthly]

    Recruiting PHASE1

▶ Show 13 earlier versions

  1. Jul 2022 — Jul 2023 [monthly]

    Recruiting PHASE1

  2. Dec 2021 — Jul 2022 [monthly]

    Recruiting PHASE1

  3. Jun 2021 — Dec 2021 [monthly]

    Recruiting PHASE1

  4. Feb 2021 — Jun 2021 [monthly]

    Recruiting PHASE1

  5. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1

  6. May 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  7. Oct 2019 — May 2020 [monthly]

    Recruiting PHASE1

  8. Feb 2019 — Oct 2019 [monthly]

    Recruiting PHASE1

  9. Jun 2018 — Feb 2019 [monthly]

    Recruiting PHASE1

  10. Feb 2018 — Jun 2018 [monthly]

    Recruiting PHASE1

  11. Oct 2017 — Feb 2018 [monthly]

    Recruiting PHASE1

  12. Jul 2017 — Oct 2017 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  13. May 2017 — Jul 2017 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Dana-Farber Cancer Institute
  • Stemline Therapeutics, Inc.
Data source: Dana-Farber Cancer Institute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations