Myelodysplastic Syndromes & Acute Myeloid Leukemia, (Connect® MDS/AML) Observational
Connect® MDS/AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
The purpose of the Connect® MDS/AML Disease Registry is to provide unique insights into treatment regimens and sequencing of these regimens as they relate to clinical outcomes of patients with newly diagnosed MDS, ICUS or AML in routine clinical practice and evaluate molecular and cellular markers that may provide further prognostic classification and/or might be predictive of therapy outcomes.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Patients must be able to provide written informed consent
- Newly diagnosed (confirmed diagnosis within 60 days prior to date of informed consent signature), primary or secondary Myelodysplastic Syndromes (MDS), or Acute Myeloid Leukemia (AML), or Idiopathic Cytopenia of Undetermined Significance (ICUS)
- Disease diagnosis confirmed by Central Eligibility Review
- AML patients must be at least 55 years of age at the time of informed consent signature
- MDS/ICUS patients must be at least 18 years of age at the time of informed consent 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
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Suspected or proven acute promyelocytic leukemia (APL) (FAB M3 or WHO 2008) based on morphology, immunophenotype, molecular assay or karyotype
- MDS, AML or ICUS cohort assignment by Central Eligibility Review is not confirmed by site
- For MDS and ICUS patients: receiving active (disease modifying) treatment** prior to ICF date (Supportive care such as transfusions, antibiotics, iron chelators, EPO, growth factors (G-CSF/GM-CSF) is allowed)
- For AML patients: receiving active (disease modifying) treatment** that had been initiated for more than 2 weeks (14 days) prior to ICF date (Supportive care, such as, transfusions, antibiotics, iron chelators, EPO, growth factors (G-CSF/GM-CSF), tumor lysis prophylaxis allowed)
To learn more, visit ClinicalTrials.Gov
Asim Pati, MD