Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
To determine the efficacy of the combination of tagraxofusp, cladribine, and cytarabine.
Eligibility criteria
Qualifiers
Documented diagnosis of relapsed or refractory acute myeloid leukemia (AML) according to World Health Organization (WHO) 2022 criteria
Expression of CD123 by either flow cytometry or immunohistochemical staining with no minimum threshold for positivity
Must have received initial therapy with venetoclax in combination with a hypomethylating agent (either azacitidine or decitabine) with no subsequent therapy unless mutations in the IDH or FLT3 genes.
Age ≥ 18 years of age
Disqualifiers
Prior therapy apart from Venetoclax in combination with a hypomethylating agent, or Venetoclax in combination with a hypomethylating agent followed by monotherapy with IDH or FLT3 inhibitors
Patients who received systemic anti-cancer therapy <14 days prior to their first day of study drug administration.
Patients who received systemic anti-cancer therapy <14 days prior to their first day of study drug administration. Concurrent hydroxyurea will be allowed. Hydroxyurea use will be allowed only during the first cycle if needed for disease control.
Significant cardiac disease (any NYHA Class 3 or 4 CHF, uncontrolled angina, history of MI, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrhythmias not controlled by medication)
Trial design
Treatments tested in this trial
- Tagraxofusp
- Cladribine (CLAD)
- Cytarabine
Treatment groups
20 Participants
are divided into 4 treatment groupsSponsors and collaborators
Stanford University
Lead sponsor
Stemline Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov