Connect Myeloid AZA-MDS-006

Condition: Myelodysplastic/Myelofibrosis



Connect Myeloid AZA-MDS-006 – Connect® Myeloid: The Myelofibrosis (MF), Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry 

Who’s Eligible:  

  • 3 open cohorts – Treated Low-Risk MDS (LR-MDS), Treated Myelofibrosis (MF), and Newly Diagnosed Low-Risk MDS (LR-MDS) 
  • For Treated LR-MDS cohort: 
    • Age: 18+ 
  • Patients who have initiated their first active treatment regimen containing at least one non-ESA therapy, within 90 days prior to ICF. 
    • Active treatment for LR-MDS includes, but is not limited to ATG, eltrombopag, HMAs, IST, lenalidomide, and luspatercept 
    • Supportive care, such as transfusions, antibiotics, antivirals, iron chelators, EPO, ESA, growth factors (G-CSF/GM-CSF), tumor lysis prophylaxis are not considered active treatments. 
  • For Treated Myelofibrosis cohort: 
    • Age: 18+ 
    • Patients who initiated their first active systemic treatment for MF and/or MF-related cytopenias within 90 days prior to the date of ICF signature. This cohort allows the enrollment of subjects with a diagnosis of MDS/MPN overlap syndromes. 
      • Active, systemic treatment for MF may include, but is not limited to hydroxyurea, JAK inhibitors, hypomethylating agents, interferon agents, and IO agents. 
      • Treatment for MF-related cytopenias may include but is not limited to steroids, ESA, danazol, lenalidomide, pomalidomide, thalidomide. 
    • Note: patients who have been on an ESA for anemia and then begin first active systemic treatment are eligible. If a patient has initiated and stopped therapy within the 90-day period due to an adverse event, they are eligible if they have not initiated a second line of therapy. 
    • MDS/MPN overlap syndromes include: Chronic myelomonocytic leukemia (CMML), Atypical chronic myeloid leukemia, BCR-ABL1 negative (aCML), Myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T), Myelodysplastic/myeloproliferative neoplasm, unclassifiable (MDS/MPN) 
  • For Newly Diagnosed LR-MDS cohort:  
    • 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 ICF 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). 
    • Age: 18+ 

If you would like more information please contact clinical trials research coordinator at DJL Research in Charlotte 704-247-9179, x-207