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Clinical Trials in Canada / NCT05564390
Recruiting Phase 2

MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

NCT05564390 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2024-06-18
Last updated
2026-09-25

Condition(s) studied

Acute Myeloid LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative NeoplasmAcute Myeloid Leukemia Post Cytotoxic TherapyAcute Myeloid Leukemia, Myelodysplasia-RelatedMyelodysplastic Syndrome

Investigational drug(s) / intervention(s)

Allogeneic Hematopoietic Stem Cell TransplantationAzacitidine →Best PracticeBiopsy ProcedureBiospecimen CollectionBone Marrow AspirationBone Marrow BiopsyBusulfan →Chest RadiographyComputed TomographyCytarabine →Daunorubicin Hydrochloride →Decitabine and Cedazuridine →Echocardiography TestEmavusertib →Enasidenib →Epoetin Alfa →Fludarabine →Gemtuzumab Ozogamicin →Gilteritinib →Liposome-encapsulated Daunorubicin-Cytarabine →Luspatercept →Melphalan →Multigated Acquisition ScanMutation Carrier ScreeningOlutasidenib →Placebo AdministrationPositron Emission TomographyTotal-Body IrradiationVenetoclax →

Allogeneic Hematopoietic Stem Cell Transplantation: Given IV

Azacitidine: Given IV or SC

Best Practice: Receive SOC treatment

Biopsy Procedure: Undergo biopsy

Biospecimen Collection: Undergo collection of blood, urine, and/or buccal swab samples

Bone Marrow Aspiration: Undergo bone marrow aspiration

Bone Marrow Biopsy: Undergo bone marrow biopsy

Busulfan: Given IV

Chest Radiography: Undergo chest x-ray

Computed Tomography: Undergo CT

Cytarabine: Given

Daunorubicin Hydrochloride: Given IV

Decitabine and Cedazuridine: Given PO

Echocardiography Test: Undergo ECHO

Emavusertib: Given PO

Enasidenib: Given PO

Epoetin Alfa: Given SC

Fludarabine: Given IV

Gemtuzumab Ozogamicin: Given IV

Gilteritinib: Given PO

Liposome-encapsulated Daunorubicin-Cytarabine: Given IV

Luspatercept: Given SC

Melphalan: Given IV

Multigated Acquisition Scan: Undergo MUGA

Mutation Carrier Screening: Undergo rapid genetic testing

Olutasidenib: Given PO

Placebo Administration: Given PO

Positron Emission Tomography: Undergo PET

Total-Body Irradiation: Undergo total body irradiation

Venetoclax: Given PO

Study summary

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. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how to treat it. Testing patients' bone marrow and blood will show doctors if patients have markers that specific drugs can target. The marker testing in this study will let doctors know if they can match patients with a treatment study (myeloMATCH clinical trial) that tests treatment for the type of cancer they have or continue standard of care treatment with their doctor on the Tier Advancement Pathway (TAP).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. * Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment. * Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy * Note: active hormonal therapy is allowed * Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration. * Participants must agree to have translational medicine specimens submitted. * Participants must be offered the opportunity to participate in specimen banking. * Note: Specimens must be collected and submitted following the initial paper-based process and subsequently via the Precision Medicine Specimen Tracking Forms in Medidata Rave instance for the MyeloMATCH MSRP. * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. * Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system. * The master screening and reassessment protocol (MSRP) should only be used in sites where the relevant AML treatment substudies are open or if the site is willing to follow the MSRP Tier Advancement Pathway (TAP) for patients in the event that the site does not have the relevant study open and transfer to another site that does have the study open. For example, if a site does not have a myeloMATCH Tier 1 study for older AML open for enrollment, such older AML patients should only be consented for the MSRP if the site is willing to treat the patient with standard of care on TAP or is willing to transfer the patient to a center with a study open that the patient would otherwise match to.

Primary outcome measure(s)

Trial sites (350)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama Recruiting
Mayo Clinic Hospital in Arizona Phoenix Arizona Recruiting
Banner University Medical Center - Tucson Tucson Arizona Recruiting
University of Arizona Cancer Center-North Campus Tucson Arizona Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
Alta Bates Summit Medical Center-Herrick Campus Berkeley California Active Not Recruiting
Kaiser Permanente Dublin Dublin California Recruiting
Kaiser Permanente-Fremont Fremont California Recruiting
Kaiser Permanente Fresno Orchard Plaza Fresno California Recruiting
Kaiser Permanente-Fresno Fresno California Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine California Recruiting
Tibor Rubin VA Medical Center Long Beach California Active Not Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
Kaiser Permanente- Modesto MOB II Modesto California Recruiting
Kaiser Permanente-Modesto Modesto California Recruiting
Kaiser Permanente-Oakland Oakland California Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California Recruiting
Kaiser Permanente-Roseville Roseville California Recruiting
Kaiser Permanente Downtown Commons Sacramento California Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California Recruiting
Kaiser Permanente-South Sacramento Sacramento California Recruiting
Kaiser Permanente-San Francisco San Francisco California Recruiting
UCSF Medical Center-Parnassus San Francisco California Recruiting
Kaiser Permanente-Santa Teresa-San Jose San Jose California Recruiting
Kaiser Permanente San Leandro San Leandro California Recruiting
Kaiser San Rafael-Gallinas San Rafael California Recruiting
Kaiser Permanente Medical Center - Santa Clara Santa Clara California Recruiting
Kaiser Permanente-Santa Rosa Santa Rosa California Recruiting
Kaiser Permanente-South San Francisco South San Francisco California Recruiting
Kaiser Permanente-Vallejo Vallejo California Recruiting
Kaiser Permanente-Walnut Creek Walnut Creek California Recruiting
Yale University New Haven Connecticut Recruiting
Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven Connecticut Recruiting
UF Health Cancer Institute - Gainesville Gainesville Florida Recruiting
Mayo Clinic in Florida Jacksonville Florida Recruiting
Miami Cancer Institute Miami Florida Recruiting
Memorial Hospital West Pembroke Pines Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Phoebe Putney Memorial Hospital Albany Georgia Recruiting
Augusta University Medical Center Augusta Georgia Recruiting

+ 310 more sites — see the full list on the official registry below.

On this site

📄 Venclexta (venetoclax) drug profile →

More National Cancer Institute (NCI) trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05564390 on ClinicalTrials.gov ↗ ← All trials in Canada