Actively Recruiting
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)
Led by Dana-Farber Cancer Institute · Updated on 2025-11-04
72
Participants Needed
3
Research Sites
518 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
S
Stemline Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of AML, MDS, or BPDCN according to 2016 WHO criteria
- CD123 / IL3RA expression on AML or MDS blasts or BPDCN cells within 3 months prior to treatment
- Age 18 years or older with relapsed or refractory AML, treatment-naive AML unfit for intensive chemotherapy, MDS with >10% myeloblasts, or relapsed/refractory BPDCN
- Adequate organ function including albumin > 3.2 g/dL, serum creatinine < 1.5x ULN, AST and ALT < 2.5x ULN, total bilirubin < 1.5x ULN (with exceptions), CPK < 2.5x ULN, and normal left ventricular ejection fraction
- For AML and BPDCN cohorts, WBC < 20,000 / uL on day of first therapy (cytoreduction allowed)
- Ability to understand and willing to sign informed consent
- Willingness and ability to adhere to study schedule and follow-up
- Women of child-bearing potential and men must agree to use adequate contraception during and for 2 months after study participation
You will not qualify if you...
- Prior treatment with venetoclax within 2 months before study therapy
- Diagnosis of acute promyelocytic leukemia
- Receipt of chemotherapy, radiation, or biologic cancer therapy within 14 days before treatment (except intrathecal chemotherapy); hydroxyurea allowed
- Hematopoietic stem cell transplantation within 60 days or active graft versus-host disease
- Active central nervous system involvement by AML or BPDCN without consecutive negative lumbar punctures
- Known HIV infection or active hepatitis B or C infection
- Significant heart or lung disease including uncontrolled heart failure, angina, hypertension, arrhythmia, recent heart attack or stroke, or prolonged QTc
- Active advanced solid tumors (except certain skin cancers) or other hematologic malignancies requiring treatment
- Pregnancy or breastfeeding
- Uncontrolled infection at enrollment
- For AML and BPDCN cohorts: gastrointestinal disorders preventing oral medication absorption or requiring intravenous nutrition
- Use of strong CYP3A inducers within 7 days before first dose for AML and BPDCN cohorts
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Andrew Lane, MD, PhD
CONTACT
V
Veronica Zehnder
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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