OncoMatch/Clinical Trials/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)
Is NCT03113643 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Azacitidine and SL-401 for acute myeloid leukemia.
Treatment: Azacitidine · SL-401 · Venetoclax — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: IL3RA overexpression
CD123 / IL3RA expression on the subject's AML or MDS blasts or BPDCN cells determined locally within 3 months of first protocol treatment
Prior therapy
Cannot have received: BCL2 inhibitor (venetoclax)
Exception: unless it was last taken >2 months before protocol therapy
Prior treatment with venetoclax [Cohorts B or C], unless it was last taken >2 months before protocol therapy
Cannot have received: chemotherapy, radiation, or biologic cancer therapy
Exception: except for intrathecal chemotherapy; prior and concurrent hydroxyurea is permitted
Received treatment with chemotherapy, radiation, or biologic cancer therapy within 14 days of first protocol treatment, except for intrathecal chemotherapy. Prior and concurrent hydroxyurea is permitted.
Cannot have received: hematopoietic stem cell transplantation
Exception: within 60 days of screening or active graft versus-host-disease
Hematopoietic stem cell transplantation (HSCT) within 60 days of screening or active graft versus-host-disease
Lab requirements
Kidney function
Serum creatinine < 1.5x ULN
Liver function
AST and ALT < 2.5x ULN; total bilirubin < 1.5x ULN (if >1.5x ULN due to Gilbert's disease or AML, must discuss with PI)
Cardiac function
Left ventricular ejection fraction > institutional lower limit of normal by MUGA scan or echocardiogram within 30 days of first protocol treatment
Albumin > 3.2 g/dL ... Serum creatinine < 1.5x ULN ... AST and ALT < 2.5x ULN ... Total bilirubin < 1.5x ULN ... CPK < 2.5x ULN ... Left ventricular ejection fraction > institutional lower limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- Dana Farber Cancer Institute · Boston, Massachusetts
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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