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NCT07439211 · ClinicalTrials.gov registry record · Phase 1
Assessing PI3K Gamma Inhibition With Azacitidine, Venetoclax and Eganelisib in Patients With Acute Myeloid Leukemia
A Phase 1 study, sponsored by Jacqueline Garcia, MD.
- Not yet
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT07439211: Clinical Trial Phase 1 study, sponsored by Jacqueline Garcia, MD.
NCT07439211 is a Phase 1 study that has not yet begun recruiting, run by Jacqueline Garcia, MD. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07439211, a Phase 1 study, has not yet begun recruiting, sponsored by Jacqueline Garcia, MD.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This study is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML). The names of the study drugs involved in this research study are: * Venetoclax (a type of BCL-2 inhibitor) * Azacitidine (a type of Demethylating Agent) * Eganelisib (a type of PI3K-gamma inhibitor)
Primary Outcome
The eganelisib (daily) RP2D in combination with azacitidine 75 mg/m\^2/day on days 1-7 and venetoclax 400 mg daily (28 days) is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The RP2D is based on the Bayesian optimal interval design (BOIN). The RP2D may also be based on available pharmacokinetic (PK) and pharmacodynamic (PD) data.
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Eganelisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2026-07 |
| Est. Completion | 2029-02-01 |
| Phase | Phase 1 |
What is known before NCT07439211 opens enrollment
NCT07439211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT07439211 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07439211 about?
NCT07439211 is a clinical study titled "Assessing PI3K Gamma Inhibition With Azacitidine, Venetoclax and Eganelisib in Patients With Acute Myeloid Leukemia". This study is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML). The names of the study drugs involved in this research ...
What is the current status of trial NCT07439211?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2026-07. Estimated completion is 2029-02-01.
What interventions are being tested in trial NCT07439211?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Eganelisib (DRUG).
Who is sponsoring clinical trial NCT07439211?
This trial is sponsored by Jacqueline Garcia, MD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07439211's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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