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NCT05442216 · ClinicalTrials.gov registry record · Phase 2
Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents
A Phase 2 study of Acute Myeloid Leukemia, sponsored by Joshua Zeidner.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 7
- Study locations
NCT05442216: Recruiting Phase 2 study of Acute Myeloid Leukemia, sponsored by Joshua Zeidner.
NCT05442216 is a Phase 2 study of Acute Myeloid Leukemia that is actively recruiting participants, run by Joshua Zeidner. The registered enrollment target is 53 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (54% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05442216, a Phase 2 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Joshua Zeidner.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 7
- Study locations
Study Summary
A treatment cycle is 28 days. Tagraxofusp will be administered at 9 mcg/kg IV over 15 minutes (-5 or +15 minutes) daily for 3 consecutive days (or 3 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution), followed by azacitidine administered at 75 mg/m2 SQ or IV daily on Day 4 through Day 10. Venetoclax will begin on Day 4 and continue through Day 24 (21 consecutive days). A bone marrow biopsy (BM Bx) will be performed on Day 24 (+3 days) of Cycle 1. Subjects who do not achieve a CRm will proceed with the next cycle of Induction Phase study treatment, irrespective of hematologic laboratory values. Cycle 2+ will consist of tagraxofusp 9 mcg/kg IV over 15 minutes daily for 3 consecutive days (Day 1-3 or 3 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution), azacitidine 75 mg/m2 SQ or IV on Day 1 through Day 7 or Days 1-7 or 1-5, 8-9 and venetoclax 400 mg daily Day 1 through Day 21. A bone marrow biopsy (BM Bx) will be performed on Day 21 (+3 days) of Cycle 2. If a CRm is obtained or maintained, the subject will move to or remain on the Continuation Phase. Subjects who do not achieve a marrow CR (CRm) after Cycle 2 will proceed with the next cycle of Induction Phase study treatment as described above, irrespective of hematologic laboratory values. If a CRm is obtained after Cycle 3 or 4, the subject will move to the Continuation Phase . If a CRm is not obtained after Cycle 4, study treatment will be discontinued and the subject will move to follow up. If per the investigator, the subject is receiving clinical benefit, study treatment may continue until toxicity or completion of 12 total cycles. A BM Bx will be performed at least every 3 cycles for these subjects.
Primary Outcome
The CR rate based on ELN AML response criteria in subjects with newly diagnosed AML with p-HMA receiving tagraxofusp and azacitidine and venetoclax
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Tagraxofusp
Study Locations (7)
Florida
- University of Miami - Miami
- AdventHealth Orlando - Orlando
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
New York
- Roswell Park Cancer Institute - Buffalo
Pennsylvania
- Penn Medicine Abramson Cancer Center - Philadelphia
Rhode Island
- Lifespan Health System Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2024-05-01 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT05442216 shows while recruiting
NCT05442216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT05442216 lists 7 locations in 5 states (Florida, North Carolina, New York).
Frequently Asked Questions
What is clinical trial NCT05442216 about?
NCT05442216 is a clinical study titled "Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents". A treatment cycle is 28 days. Tagraxofusp will be administered at 9 mcg/kg IV over 15 minutes (-5 or +15 minutes) daily for 3 consecutive days (or 3 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution), followed by azacitidine administered at 75 mg/...
What is the current status of trial NCT05442216?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2024-05-01. Estimated completion is 2027-12.
What conditions does trial NCT05442216 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT05442216?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Tagraxofusp (DRUG).
Who is sponsoring clinical trial NCT05442216?
This trial is sponsored by Joshua Zeidner, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05442216 being conducted?
This trial has 7 study locations across Florida, New York, North Carolina, Pennsylvania, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05442216's enrollment target sits among peer trials
53 137th of 306 higher than 170 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
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