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Title Connect® MDS and AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry

IRB CLGN2913

CC 121402C

Hospital Main Campus

Disease Leukemia - Acute Myeloid (AML), Myelodisplastic Syndrome (MDS)

Primary Objectives

To describe current and evolving patterns for diagnosis, treatment, clinical monitoring and outcome measures in patients with LR or HR MDS, MDS risk not determined, and AML
To compare routine clinical practice patterns with existing management guidelines, e.g., NCCN
To describe treatment patterns and outcomes in patients with del(5q) cytogenetic abnormality, with or without additional cytogenetic abnormalities
To summarize patient-reported HRQoL outcomes and economic outcomes, and their association with patient characteristics, treatment regimens, and clinical outcomes

Exploratory Objectives

To evaluate molecular and/or cellular markersi in the blood/BM tissues and oral epithelial cellsk that may provide further prognostic classification of MDS and AML subtypes as well as a chance to evaluate their potential impact on treatment outcomes
To evaluate molecular and/or cellular markers in the blood/BM tissues and oral epithelial cells during therapy that may provide information on drug mechanism of action and on-therapy markers predictive of clinical outcomes
To summarize the clinical status (e.g., Overall survival [OS], Progression-free survival [PFS], Response rate [RR]) of patients with or without mutations by treatment regimen
To analyze the correlation between mutation detection/allele burden in bone marrow and peripheral blood samples

Patients must be able to provide written informed consent form (ICF)
Newly diagnosed, primary or secondary MDS or AML
Cohort assignment confirmed by Central Eligibility Review
MDS patients of unknown-risk must have undergone 2 BM testings with failed cytogenetics
AML patients must be at least 55 years of age at the time of ICF signature
MDS patients must be at least 18 years of age at the time of ICF signature
Patients must be willing and able to complete enrollment and follow-up HRQoL instruments, for which patients must be proficient in either English or Spanish

Suspected or proven acute promyelocytic leukemia (APL) (F AB M3 or WHO 2008) based on morphology, immunophenotype, molecular assay, or karyotype
MDS or AML cohort assignment by Central Eligibility Review is not confirmed by site
Treatment with active (disease modifying) agents for MDS or AML prior to ICF date. (Supportive care (growth factors, transfusions, etc.) is allowed.)

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