MYELOMATCH

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

Objective

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)

Study Arms

  • Experimental: Screening (mutation carrier screening)

  • Experimental: TAP (SOC treatment, mutation carrier screening)

  • Active Comparator: MM1MDS-A01 Arm A (ASTX727)
  • Experimental: MM1MDS-A01 Arm B (ASTX727, enasidenib) 
  • Experimental: MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)
  • Active Comparator: MM1OA-S03 Arm 1 (ASTX727, venetoclax)
  • Experimental: MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)
  • Active Comparator: MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)
  • Experimental: MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)
  • Experimental: MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)
  • Experimental: MM1YA-CTG01 Arm II (azacitidine, venetoclax)
  • Active Comparator: MM1YA-CTG01 Arm III (daunorubicin, cytarabine)
  • Active Comparator: MM1YA-S01 Arm I (cytarabine, daunorubicin)
  • Experimental: MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)
  • Experimental: MM1YA-S01 Arm III (azacitidine, venetoclax)
  • Experimental: MM1YA-S01 Arm IV (Vyxeos)
  • Experimental: MM1YA-S01 Arm V (Vyxeos, venetoclax)
  • Active Comparator: MM2YA-EA01 Arm A (cytarabine)
  • Experimental: MM2YA-EA01 Arm B (cytarabine, venetoclax)
  • Experimental: MM2YA-EA01 Arm C (Vyxeos, venetoclax)
  • Experimental: MM2YA-EA01 Arm D (azacitidine, venetoclax)
  • Experimental: MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)
  • Placebo Comparator: MM3TCT-A03 Conditioning 1B (matched donors with placebo
  • Experimental: MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)
  • Placebo Comparator: MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)
  • Experimental: MM3TCT-A03 Maintenance I (venetoclax)
  • Placebo Comparator: MM3TCT-A03 Maintenance II (placebo)

Eligibility

  • 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.

NCT ID

NCT06890884

Want to learn more? Visit ClinicalTrials.gov.

Principal Investigator(s)
Status
Open and enrolling
Start Date