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)
NCT03113643 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2025-11-04
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
Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Blastic Plasmacytoid Dendritic Cell Neoplasm
Interventions
- DRUG
-
Chemotherapy
- DRUG
-
SL-401
SL-401 works by targeting leukemia cells (blasts), and also possibly by stopping or slowing the growth of cancer stem cells, which are the undeveloped cells which can develop into cancer cells.
- DRUG
-
Venetoclax is a BH3-mimetic. Venetoclax blocks the anti-apoptotic B-cell lymphoma-2 (Bcl-2) protein, leading to programmed cell death of CLL cells. Overexpression of Bcl-2 in some lymphoid malignancies has sometimes shown to be linked with increased resistance to chemotherapy.
Sponsors & Collaborators
-
Stemline Therapeutics, Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Andrew Lane, MD, PhD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-26
- Primary Completion
- 2026-05-31
- Completion
- 2027-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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