NCT05442216 · Joshua Zeidner
Tagraxofusp and Azaxitadine With or Without Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents
(TAGALONG)
What this study is about
A treatment cycle is 28 days for Cycle 1 and Cycle 2. Tagraxofusp will be administered at 12 mcg/kg IV over 15 minutes (-5 or +15 minutes) daily for 5 consecutive days (or 5 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution).
View original scientific description
A treatment cycle is 28 days for Cycle 1 and Cycle 2. Tagraxofusp will be administered at 12 mcg/kg IV over 15 minutes (-5 or +15 minutes) daily for 5 consecutive days (or 5 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution). Subjects with a marrow CR (See the protocol) after Cycle 2 will continue Tagraxofusp for Cycles 3 to 12 (up to 1 year of treatment) at 12 mcg/kg IV for 5 consecutive days every 28 days.
Interventions
DRUG
Tagraxofusp
9 mcg/kg intravenously Days 1-3
DRUG
Azacitidine
75 mg/m2 subcutaneously or intravenously Days 1-7
DRUG
Venetoclax
400 mg daily Days 1-21.
Primary outcome measures
Complete Response
Time frame: 5 years
The CR rate based on ELN AML response criteria in subjects with newly diagnosed AML with p-HMA receiving tagraxofusp and azacitidine and venetoclax
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Subjects must have newly diagnosed, untreated AML, as defined by ≥ 20% blasts in peripheral blood or bone marrow by manual aspirate differential, immunohistochemistry staining, or flow cytometry, as defined by standard WHO 2016 diagnostic criteria.
- Subjects must have documented CD123 positivity on leukemia cells by a centralized flow cytometry assay (Hematologics).
- Documented diagnosis of prior MDS, CMML, MDS/MPN overlap syndromes, or MPN's according to WHO criteria. Subjects must have received at least 2 cycles of hypomethylating agents (azacitidine or decitabine or oral decitabine/cedazuridine) for the management of MDS, CMML, MDS/MPN overlap syndromes, or MPN's. NOTE: Subjects who have enrolled on clinical trials with investigational agents in combination with HMA's will still be eligible. Investigational agents must have been discontinued \>21 days prior to
Where
- Miami, Florida
- Orlando, Florida
- Buffalo, New York
- Chapel Hill, North Carolina
- Winston-Salem, North Carolina
- Philadelphia, Pennsylvania
- Providence, Rhode Island
Collaborators
Stemline Therapeutics, Inc., University of North Carolina, Chapel Hill
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations