NCT05564390 · National Cancer Institute (NCI)
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
What this study is about
This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers.
View original scientific description
This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured.
Interventions
PROCEDURE
Allogeneic Hematopoietic Stem Cell Transplantation
Given IV
DRUG
Azacitidine
Given IV or SC
OTHER
Best Practice
Receive SOC treatment
PROCEDURE
Biopsy Procedure
Undergo biopsy
PROCEDURE
Biospecimen Collection
Undergo collection of blood, urine, and/or buccal swab samples
PROCEDURE
Bone Marrow Aspiration
Undergo bone marrow aspiration
PROCEDURE
Bone Marrow Biopsy
Undergo bone marrow biopsy
DRUG
Busulfan
Given IV
PROCEDURE
Chest Radiography
Undergo chest x-ray
PROCEDURE
Computed Tomography
Undergo CT
DRUG
Cytarabine
Given
DRUG
Daunorubicin Hydrochloride
Given IV
DRUG
Decitabine and Cedazuridine
Given PO
PROCEDURE
Echocardiography Test
Undergo ECHO
BIOLOGICAL
Emavusertib
Given PO
DRUG
Enasidenib
Given PO
BIOLOGICAL
Epoetin Alfa
Given SC
DRUG
Fludarabine
Given IV
DRUG
Gemtuzumab Ozogamicin
Given IV
DRUG
Gilteritinib
Given PO
DRUG
Liposome-encapsulated Daunorubicin-Cytarabine
Given IV
BIOLOGICAL
Luspatercept
Given SC
DRUG
Melphalan
Given IV
PROCEDURE
Multigated Acquisition Scan
Undergo MUGA
PROCEDURE
Mutation Carrier Screening
Undergo rapid genetic testing
DRUG
Olutasidenib
Given PO
DRUG
Placebo Administration
Given PO
PROCEDURE
Positron Emission Tomography
Undergo PET
RADIATION
Total-Body Irradiation
Undergo total body irradiation
DRUG
Venetoclax
Given PO
Primary outcome measures
Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignment
Time frame: Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy
Will evaluate the feasibility of MATCHBox generating all data needed for assignment to a myeloMATCH clinical trial or determination that no assignment is available, within 72 hours of MDNet receipt of specimens for initial therapy and within 10 days for subsequent therapy. For first treatment assignment and separately for each subsequent treatment assignments: every 50 participants for the first 250 participants and then every 100 participants thereafter, the proportion of participants (cumulative and new participants since prior analysis) with all MDNet data needed to determine a treatment assignment within 72 hours for first assignment and 10 days for subsequent assignments after the MDNet receives specimens will be tallied.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS.
- Participants must be \>= 18 years of age.
- Participants must not have received prior anti-cancer therapy for AML or MDS.
- Note: Hydroxyurea to control the white blood cell count (WBC) is allowed.
- Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction.
- Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure. *
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Berkeley, California
- Dublin, California
- Fremont, California
- Fresno, California
- Irvine, California
- Long Beach, California
- Los Angeles, California
- Modesto, California
And 250 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
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.
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.
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.
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.
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.
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.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations