Allegheny Health Network
Find a
Doctor
Request An Appointment Login to
MyChart
Patient
Center
News Classes &
Events
Contact
Us
Call 412.Doctors

Active Clinical Trials

Connect MDS-AMLV Registry

Active NCT:
01688011
West Penn Hospital
West Penn Hospital

Category:
Cancer - Blood
Sponsor: 
Celgene
Contact: 

For more information, please contact Rich Wonder at 412-578-4492 or Rich.Wonder@ahn.org or Melissa McMillen at 412-578-4493 or Melissa.McMillen@ahn.org.

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

Purpose: 

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 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.

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

 

Study Population: Approximately 1,500 patients across approximately 200 sites throughout the US will be enrolled in the Connect® MDS and AML Registry. Sites will include both community-based and academic centers that are representative of where patients with MDS and AML are diagnosed and treated. To best capture the distribution of sites with regard to the settings of where MDS and AML patients are typically treated in routine practice, approximately 70-80% of the sites will be community hematology/oncology clinics and approximately 20-30% will be academic-based institutions.

Inclusion Criteria:

 

  • Patients must be able to provide written informed consent
  • Newly diagnosed (confirmed diagnosis within 60 days prior to enrollment), primary or secondary Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)
  • Cohort assignment confirmed by Central Eligibility Review
  • MDS patients of unknown-risk must have undergone two (2) bone marrow tests with failed cytogenetics
  • AML patients must be at least 55 years of age at the time of informed consent signature
  • MDS 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

Exclusion Criteria:

 

  • Suspected or proven acute promyelocytic leukemia (APL) (FAB M3 or WHO 2008) based on morphology, immunophenotype, molecular assay, or karyotypeMDS 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.)