MYELOMATCH, MASTER SCREENING AND REASSESSMENT PROTOCOL FOR TIER ADVANCEMENT IN THE NCI MYELOMATCH CLINICAL TRIALS

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).

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.