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NCT05520567 · ClinicalTrials.gov registry record · Phase 1
A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia
A Phase 1 study of Acute Myeloid Leukemia (AML) and FLT3-mutated Acute Myeloid Leukemia, sponsored by Astellas Pharma Global Development.
- Active
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT05520567: Active Phase 1 study of Acute Myeloid Leukemia (AML) and FLT3-mutated Acute Myeloid Leukemia, sponsored by Astellas Pharma Global Development.
NCT05520567 is a Phase 1 study of Acute Myeloid Leukemia (AML) and FLT3-mutated Acute Myeloid Leukemia that is active but no longer recruiting, run by Astellas Pharma Global Development. The registered enrollment target is 70 participants, below the 143-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05520567, a Phase 1 study of Acute Myeloid Leukemia (AML) and FLT3-mutated Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Astellas Pharma Global Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
Study Summary
People with acute myeloid leukemia (AML) are usually treated with chemotherapy. Some people with AML have a changed FLT3 gene which causes leukemia cells to grow faster. Therefore, chemotherapy is less suitable to treat AML in people with the changed FLT3 gene. Gilteritinib, given with venetoclax and azacitidine, is a potential new treatment for people with AML with the changed FLT3 gene. They cannot have chemotherapy due to old age or other conditions. Before these combined 3 medicines are available as a treatment, the researchers need to understand how they are processed by and act upon the body when given together. In this study, they do this to find a suitable dose for venetoclax and to check for potential medical problems from the treatment. In this study, people newly diagnosed with AML who have the changed FLT3 gene and cannot have chemotherapy can take part. The main aims of this study are: to find suitable doses of gilteritinib, venetoclax and azacitidine as a combined treatment; to learn how they are processed by and act upon the body; to learn the remission rate; to check for medical problems during this treatment. In the study, people will visit the study clinic many times. The first visit is to check if they can take part. People will be asked about their medical history, have a medical examination, and have their vital signs checked. Also, they will have an ECG to check their heart rhythm and have some blood and urine samples taken for laboratory tests. They will have a chest X-ray and a bone marrow sample will be taken. The changed FLT3 gene will be confirmed, either by the bone marrow or a blood sample. This study will be in 2 phases. In Phase 1, different small groups of people will take venetoclax tablets containing lower to higher doses in the combined treatment. The doses of gilteritinib and azacytidine will be unchanged. This is done to find a suitable dose of venetoclax to use in phase 2 of the study. People will take tablets of gilteriti
Primary Outcome
A DLT is defined as any of the events meeting DLT criteria that occur with the first dose on Cycle 1 Day 1 (C1D1) and that is considered to be possibly or probably related to the study treatment regimen.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Gilteritinib
Study Locations (20)
California
- City of Hope Nat'l Medical Center - Duarte
- Univ. of California - Irvine - Irvine
- UCLA Medical Center - Los Angeles
New York
- Roswell Park Cancer Institute - Buffalo
- Weill Cornell Medical College - New York
- Motefiore-Einstein Center for Cancer Care - The Bronx
Illinois
- University of Chicago - Chicago
- Robert H. Lurie Comprehensive Cancer Center - Chicago
Maryland
- University of Maryland - Baltimore
- Johns Hopkins University - Baltimore
Pennsylvania
- University of Pennsylvania-Abramson CCC-Dept. of Hem Onc - Philadelphia
- Thomas Jefferson University Hospital - Philadelphia
Colorado
- Sarah Cannon Research Institute - Denver
Florida
- Memorial Cancer Institute - Pembroke Pines
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-01-31 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 1 |
What the registry record for NCT05520567 still lists
NCT05520567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 143-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (51% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT05520567 names 20 study sites across 13 states, led by California, New York, Illinois.
Frequently Asked Questions
What is clinical trial NCT05520567 about?
NCT05520567 is a clinical study titled "A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia". People with acute myeloid leukemia (AML) are usually treated with chemotherapy. Some people with AML have a changed FLT3 gene which causes leukemia cells to grow faster. Therefore, chemotherapy is less suitable to treat AML in people with the changed FLT3 gene. Gilteritinib, given with venetoclax a...
What is the current status of trial NCT05520567?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2023-01-31. Estimated completion is 2028-07-31.
What conditions does trial NCT05520567 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML), FLT3-mutated Acute Myeloid Leukemia.
What interventions are being tested in trial NCT05520567?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Gilteritinib (DRUG).
Who is sponsoring clinical trial NCT05520567?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05520567 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05520567's enrollment target sits among peer trials
70 16th of 29 higher than 14 of 29 other Acute Myeloid Leukemia (AML) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia (AML) 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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