Connect® Myeloid Disease Registry

Inclusion Criteria

• 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. 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 60 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.

Exclusion Criteria

• Suspected or proven acute promyelocytic leukemia (APL) (FAB M3 or WHO 2008) based on morphology, immunophenotype, molecular assay or karyotype
• Currently enrolled in any interventional clinical trial where the patient is being treated with an investigational product that cannot be identified.
• Idiopathic Cytopenias of Undetermined Significance (ICUS), Myelodysplastic Syndromes (MDS) patients who received or are receiving active (disease modifying) therapy for the treatment of MDS prior to the date of informed consent.
• Acute Myeloid Leukemia (AML) patients who initiated active (disease modifying treatment for AML more than 2 weeks prior to the date of consent.
• Myelodysplastic/Myeloproliferative (MDS/MPN) overlap syndrome patients with suspected or proven excluding juvenile myelomonocytic leukemia.

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.

Trial Phase Phase NA

Trial Type Not provided by clinicaltrials.gov

Lead Organization
Celgene Corporation

• Primary ID Connect® MDS/AML Registry
• Secondary IDs NCI-2015-01815
• Clinicaltrials.gov ID NCT01688011