MyeloMATCH MSRP: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study

• Status: Not yet recruiting
• Trial end date: 2032-05-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Azacitidine; Cytarabine; Daunorubicin; Venetoclax

Criteria

Inclusion Criteria:

• Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). For participants assigned an AML basket protocol, there cannot be a history of previous myeloproliferative neoplasm (MPN) or MDS.

• Participants must be >= 18 years of age.

• Participants must agree to have specimens submitted. Note: Email notification of treatment protocol assignment must be received prior to treatment protocol registration.

• Participants must be offered the opportunity to participate in specimen banking. Note:

With participant consent, specimens must be collected and submitted via the Clinical/Correlative Sample Management System (CSMS).

• 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) is only used in sites where the relevant AML clinical trials are 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 not be consented for the MSRP

Exclusion Criteria:

• 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.

• Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy

• Note: active hormonal therapy is allowed