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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 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.

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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

Conditions Studied

Acute Myeloid Leukemia (AML) FLT3-mutated Acute Myeloid Leukemia

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

FieldValue
Enrollment Target 70 participants
Start Date 2023-01-31
Est. Completion 2028-07-31
Phase Phase 1

Sponsor

Astellas Pharma Global Development

168 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05520567

The ClinicalTrials.gov registry entry for NCT05520567 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 143-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (51% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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