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NCT05455294 · ClinicalTrials.gov registry record · Phase 1
Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Jacqueline Garcia, MD.
- Active
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 3
- Study locations
NCT05455294: Active Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Jacqueline Garcia, MD.
NCT05455294 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is active but no longer recruiting, run by Jacqueline Garcia, MD. The registered enrollment target is 16 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (86% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05455294, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by Jacqueline Garcia, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this research study is to test the safety of a new three drug combination of navitoclax, decitabine, and venetoclax to treat advanced myeloid malignancies. The names of the drugs involved in this study are: * Venetoclax * Decitabine * Navitoclax
Primary Outcome
The RP2D is the minimally safe and biologically effective dose. The minimally safe dose is the highest dose level at which \<2 of 6 participants experience a dose limiting toxicity (DLT). See subsequent primary outcome for the DLT definition. With respect to safety, the RP2D will also consider laboratory evidence of platelet recovery. Evaluation of efficacy will be done in real time prioritizing full complete response (see subsequent secondary outcome for the objective response criteria) when po
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Decitabine
- DRUG Navitoclax
Study Locations (3)
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana Farber Cancer Institute - Boston
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-07-18 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT05455294 still lists
NCT05455294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (86% lower).
The record links to 5 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT05455294 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05455294 about?
NCT05455294 is a clinical study titled "Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms". The purpose of this research study is to test the safety of a new three drug combination of navitoclax, decitabine, and venetoclax to treat advanced myeloid malignancies. The names of the drugs involved in this study are: * Venetoclax * Decitabine * Navitoclax
What is the current status of trial NCT05455294?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2022-07-18. Estimated completion is 2026-12-31.
What conditions does trial NCT05455294 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelofibrosis, Myeloproliferative Neoplasm, Myeloid Malignancy.
What interventions are being tested in trial NCT05455294?
The interventions under investigation include: Venetoclax (DRUG), Decitabine (DRUG), Navitoclax (DRUG).
Who is sponsoring clinical trial NCT05455294?
This trial is sponsored by Jacqueline Garcia, MD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05455294 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05455294's enrollment target sits among peer trials
16 269th of 306 higher than 34 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.
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