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Screening to match myeloid cancer patients with treatment options

Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials

Phase 2 Interventional National Cancer Institute (NCI) · NCT05564390

This study is testing a new way to help people with acute myeloid leukemia or myelodysplastic syndrome find the right treatment options faster by checking their blood and bone marrow for specific markers.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment2000 (estimated)
Ages18 Years and up
SexAll
SponsorNational Cancer Institute (NCI) NIH
Drugs / interventionsgemtuzumab, gilteritinib, fludarabine
Locations347 sites (Birmingham, Alabama and 346 other locations)
Trial IDNCT05564390 on ClinicalTrials.gov

What this trial studies

This study evaluates a screening tool and laboratory tests to improve the ability of patients with acute myeloid leukemia or myelodysplastic syndrome to enroll in clinical trials or receive standard care. It involves testing patients' bone marrow and blood for specific biomarkers that can inform treatment decisions. The study aims to organize data for treatment assignment within a short timeframe and allows patients not matched to investigational treatments to continue receiving standard care while remaining eligible for future treatment options.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are suspected to have untreated acute myeloid leukemia or myelodysplastic syndrome.

Not a fit: Patients with a history of previously treated myeloproliferative neoplasms or those currently receiving cytarabine-containing therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment personalization and improve outcomes for patients with myeloid cancers.

How similar studies have performed: Other studies have shown promise in using biomarker-driven approaches for matching cancer treatments, indicating potential success for this method.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 346 other locations

+297 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative NeoplasmAcute Myeloid Leukemia Post Cytotoxic TherapyAcute Myeloid Leukemia, Myelodysplasia-RelatedMyelodysplastic Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.