Connect® Myeloid Disease Registry
Cancer-Related Syndrome
Leukemia
Myelodysplastic Syndromes (MDS)
18 Years and older, Male and Female
Connect® MDS/AML Registry (primary)
Summary
The purpose of the Connect® Myeloid disease registry is to provide unique insights into
treatment decisions and treatment patterns as they relate to clinical outcomes of
patients with myeloid diseases in routine clinical practice. This disease registry will
also evaluate molecular and cellular markers that may provide further prognostic
classification which may or may not be predictive of therapy and clinical outcomes.
Objectives
This Disease Registry will collect data on patient characteristics, treatment patterns
and clinical outcomes. The objective is to describe how patients with myeloid diseases
are treated; and to build a knowledge base regarding the effectiveness and safety of
first line and subsequent treatment regimens in both community and academic settings.
Enrolled patients will receive treatment and evaluations for their disease according to
the standard of care and routine clinical practice at each study site. All treatments
that patients receive for their disease will be recorded, including initial treatment and
any subsequent therapy. Data on treatment outcomes, including response rates as measured
by the treating physician, evidence of progression, survival, and patient-reported
outcomes will be collected quarterly on the electronic CRF.
Eligibility
- Patients must be able to provide written informed consent form (ICF)
- Must be willing and able to complete baseline and follow-up HRQoL instruments, for which patients must be proficient in either English or Spanish
- AML patients must be at least 55 years of age at the time of informed consent.
- MF, ICUS, and MDS patients must be at least 18 years of age at the time of informed consent. Newly diagnosed Idiopathic Cytopenias of Undetermined Significance (ICUS),
Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML) patients:
- Newly diagnosed primary or secondary disease. To be considered "newly diagnosed", a patient's confirmed diagnosis must be made no more than 60 days prior to the date of consent signature. (An additional 5-day window [i.e., up to 65 days prior to the date of ICF signature] may be allowed in special circumstance upon sponsor approval)
- Cohort assignment confirmed by central eligibility review. Cohort assignment must also be confirmed by the site. Myelofibrosis (MF) patients:
- Patients who initiated their first active systemic treatment for MF and/or MF-related cytopenias within 90 days prior to the date of consent signature. This cohort allows the enrollment of subjects with a diagnosis of Myelodysplastic/Myeloproliferative overlap syndromes (MDS/MPN overlap syndrome).
- Cohort assignment is confirmed by the site. Central eligibility review is not required. Treated Lower-Risk Myelodysplastic Syndromes (LR-MDS) patients:
- Patients who have initiated first active treatment regimen containing at least one non-ESA therapy, within 90 days prior to ICF
- Cohort assignment is confirmed by site. Central eligibility review is not required. Luspatercept treated patients:
- Patient must have been at least 18 years of age at the start of luspatercept.
- Among LR-MDS patients, patient must have initiated luspatercept on or after September 1, 2023, must be ESA-naïve and luspatercept must be the first active treatment (as monotherapy or part of a treatment regimen) for their disease.
- Among all other myeloid malignancies, there is no date restriction for initiation of luspatercept .Patient may have received prior treatment for their disease.
- Patient must have at least 3 months of follow-up from start of luspatercept treatment at the participating site.
Treatment Sites in Georgia
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