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NCT04817241 · ClinicalTrials.gov registry record · Phase 1
Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients
A Phase 1 study of Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 7
- Study locations
NCT04817241: Active Phase 1 study of Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).
NCT04817241 is a Phase 1 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 5 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (96% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04817241, a Phase 1 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 7
- Study locations
Study Summary
This phase Ib/II trial studies the effects of ASTX727 (decitabine and cedazuridine) in combination with venetoclax in treating patients with higher-risk acute myeloid leukemia patients who do not have a change in the gene called fms-like tyrosine kinase 3 (FLT3). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is an enzyme inhibitor. It helps to increase the amount of decitabine in the body so that the medication will have a greater effect. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Venetoclax and decitabine are commonly given together for older patients with AML ASTX727 (a pill form of decitabine + cedazuridine) has been found to be equal to decitabine (given intravenously), and this part of the study is to confirm that venetoclax and ASTX727 is as safe as venetoclax and decitabine given intravenously. This study allows for lowering doses of study drugs to assure the dose chosen for the randomized study (second portion of this trial) is safe and tolerable for people. Giving ASTX727 in combination with venetoclax may help in the treatment of patients with higher-risk acute myeloid leukemia.
Primary Outcome
The highest dose level in which at most 1 patient in 6 experiences dose-limiting toxicity (DLT).
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Cytarabine
- DRUG Daunorubicin
- DRUG Decitabine and Cedazuridine
- PROCEDURE Bone Marrow Aspiration and Biopsy
Study Locations (7)
New York
- Roswell Park Cancer Institute - Buffalo
- Montefiore Medical Center-Einstein Campus - The Bronx
- Montefiore Medical Center - Moses Campus - The Bronx
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Connecticut
- Yale University - New Haven
Tennessee
- Vanderbilt University/Ingram Cancer Center - Nashville
Virginia
- University of Virginia Cancer Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2022-02-10 |
| Est. Completion | 2026-11-05 |
| Phase | Phase 1 |
What the registry record for NCT04817241 still lists
NCT04817241 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04817241 lists 7 locations in 5 states (New York, Alabama, Connecticut).
Frequently Asked Questions
What is clinical trial NCT04817241 about?
NCT04817241 is a clinical study titled "Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients". This phase Ib/II trial studies the effects of ASTX727 (decitabine and cedazuridine) in combination with venetoclax in treating patients with higher-risk acute myeloid leukemia patients who do not have a change in the gene called fms-like tyrosine kinase 3 (FLT3). Decitabine is in a class of medicati...
What is the current status of trial NCT04817241?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2022-02-10. Estimated completion is 2026-11-05.
What conditions does trial NCT04817241 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT04817241?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Cytarabine (DRUG), Daunorubicin (DRUG), Decitabine and Cedazuridine (DRUG), Bone Marrow Aspiration and Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT04817241?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04817241 being conducted?
This trial has 7 study locations across Alabama, Connecticut, New York, Tennessee, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04817241's enrollment target sits among peer trials
5 305th of 306 higher than 2 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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