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A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia

Sponsored by Astellas Pharma Global Development, Inc.

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Jan 26, 2026

Phase

Clinical Trial

Sponsor

Astellas Pharma Global Development, Inc.

Enrollment Target

70

Start Date

Jan 2023

๐Ÿ“Š
1 of 70 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Participant has a diagnosis of previously untreated Acute Myeloid Leukemia (AML) according to World Health Organization classification as determined by pathology review at the treating institution.
Participant is positive for FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication \[ITD\] and/or tyrosine kinase domain \[TKD\] \[D835/I836\] mutation) in bone marrow or whole blood as determined by the central laboratory. A participant with rapidly proliferative disease and unable to wait for the central laboratory results can be enrolled from a local test result.
Participant is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:
Participant is \>= 75 years of age with Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
Participant is \>= 18 to 75 years of age and has any of the following comorbidities: ECOG performance status 2 or 3, cardiac history of congestive heart fai

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

70 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Astellas Pharma Global Development, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Duarte

California

Location available
View Duarte location page
RECRUITING

Irvine

California

Location available
View Irvine location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

Denver

Colorado

Location available
View Denver location page
RECRUITING

Pembroke Pines

Florida

Location available
View Pembroke Pines location page
RECRUITING

Chicago

Illinois

Location available
View Chicago location page
RECRUITING

Chicago

Illinois

Location available
View Chicago location page
RECRUITING

Baltimore

Maryland

Location available
View Baltimore location page
RECRUITING

Baltimore

Maryland

Location available
View Baltimore location page

๐Ÿ“ And 11 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Find More Leukemia Trials by City

Browse all leukemia clinical trials in these cities โ€” not just this study.

Looking for Acute Myeloid Leukemia Treatment in Duarte?

Join others in California exploring innovative treatment options through clinical research

Acute Myeloid Leukemia Treatment Options in Duarte, California

If you're searching for Acute Myeloid Leukemia treatment in Duarte, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Duarte, Irvine, Los Angeles and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Acute Myeloid Leukemia. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 70 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Acute Myeloid Leukemia?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Acute Myeloid Leukemia

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Acute Myeloid Leukemia Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05520567. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.