Clinical Trial: 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)
Status:
RECRUITINGPhase:
Phase 1| Lead Sponsor: | Dana-Farber Cancer Institute |
| Information Provided By: | Dana-Farber Cancer Institute |
| Last Update Posted: | 2026-06-17 |
Study Overview
Brief 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
Official Title
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)
Conditions
Acute Myeloid Leukemia, Myelodysplastic Syndrome, Blastic Plasmacytoid Dendritic Cell Neoplasm
Intervention / Treatment
- Drug: Azacitidine
- Drug: SL-401
- Drug: Venetoclax
Other Study ID Numbers
- 17-056
Start Date (Actual)
2017-06-26
Primary Completion Date (Actual)
2021-09-15
Study Completion Date (Estimated)
2027-05-31
Enrollment (Estimated)
72
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Dana-Farber Cancer Institute |
| Information Provided By: | Dana-Farber Cancer Institute |
| Last Update Posted: | 2026-06-17 |
Study Overview
Brief 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
Official Title
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)
Conditions
Acute Myeloid Leukemia, Myelodysplastic Syndrome, Blastic Plasmacytoid Dendritic Cell Neoplasm
Intervention / Treatment
- Drug: Azacitidine
- Drug: SL-401
- Drug: Venetoclax
Other Study ID Numbers
- 17-056
Start Date (Actual)
2017-06-26
Primary Completion Date (Actual)
2021-09-15
Study Completion Date (Estimated)
2027-05-31
Enrollment (Estimated)
72
Study Type
Interventional
Phase
Phase 1