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RECRUITING Phase 2

Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

NCT05554406 · View on ClinicalTrials.gov ↗

Study Summary

This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a class of medications called anthracyclines. It also works by slowing or stopping the growth of cancer cells in the body. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. There is evidence that these newer experimental treatment regimens may work better in getting rid of more AML compared to the standard approach of cytarabine and daunorubicin.

Interventions

  • DRUG Azacitidine
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • DRUG Cytarabine
  • DRUG Daunorubicin Hydrochloride

Study Locations (20)

California

  • Alta Bates Summit Medical Center-Herrick Campus — Berkeley
  • Cedars Sinai Medical Center — Los Angeles
  • University of California Davis Comprehensive Cancer Center — Sacramento
  • UCSF Medical Center-Parnassus — San Francisco
  • Mills Health Center — San Mateo

Hawaii

  • Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu
  • Straub Clinic and Hospital — Honolulu
  • Kapiolani Medical Center for Women and Children — Honolulu
  • Hawaii Cancer Care - Westridge — ‘Aiea
  • Pali Momi Medical Center — ‘Aiea

Arizona

  • Mayo Clinic Hospital in Arizona — Phoenix
  • Banner University Medical Center - Tucson — Tucson
  • University of Arizona Cancer Center-North Campus — Tucson

Florida

  • Mayo Clinic in Florida — Jacksonville
  • Miami Cancer Institute — Miami

Georgia

  • Phoebe Putney Memorial Hospital — Albany
  • Augusta University Medical Center — Augusta

Alabama

  • University of Alabama at Birmingham Cancer Center — Birmingham

Arkansas

  • University of Arkansas for Medical Sciences — Little Rock

Connecticut

  • Yale University — New Haven

Trial Details

FieldValue
Enrollment Target 335 participants
Start Date 2024-09-25
Est. Completion 2027-03-31
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05554406

The ClinicalTrials.gov registry entry for NCT05554406 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 335 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Azacitidine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05554406 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Hawaii, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05554406 about?

NCT05554406 is a clinical study titled "Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)". This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabin...

What is the current status of trial NCT05554406?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 335 participants. The study started on 2024-09-25. Estimated completion is 2027-03-31.

What conditions does trial NCT05554406 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm, Acute Myeloid Leukemia, Myelodysplasia-Related. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05554406?

The interventions under investigation include: Azacitidine (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Cytarabine (DRUG), Daunorubicin Hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05554406?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05554406 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial