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, 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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Lower-Risk Myelodysplastic Syndromes (LR MDS) Newly diagnosed lower risk MDS patients as determined by International Prognostic Scoring System (IPSS).
Higher-Risk Myelodysplastic Syndromes (HR MDS) Newly diagnosed higher risk MDS patients as determined by International Prognostic Scoring System (IPSS).
Acute Myeloid Leukemia (AML) Newly diagnosed AML patients (≥55 years old, excluding patients with acute promyelocytic leukemia (APL).
Idiopathic Cytopenia of Undetermined Significance (ICUS) Newly diagnosed ICUS patients as determined by clinical criteria defined by Valent et al. (Valent P, Horny H-P, Bennett JM et al. 2007. Definitions and standards in the diagnosis and treatment of the myelodysplastic syndromes: Consensus statements and report from a working conference. Leukemia Research. 31: 727-736. And further updated Valent P, Bennett JM et al. 2017. Proposed minimal diagnostic criteria for myelodysplastic syndromes (MDS) and potential pre-MDS conditions. Oncotarget. 8(43): 73483-73500.)

Recruiting Locations

UTMB Galveston
Galveston, Texas 77573

More Details

NCT ID
NCT01688011
Status
Recruiting
Sponsor
Celgene

Study Contact

Melissa Nifenecker
908-219-0809
connectmdsaml-registry@celgene.com

Detailed Description

This Disease Registry will collect data on patient characteristics, treatment patterns and clinical outcomes. The objective is to describe how newly diagnosed MDS, ICUS or AML patients are treated; and to build a knowledge base regarding the effectiveness and safety of front-line and subsequent treatment regimens in both community and academic settings. Enrolled patients will receive treatment and evaluations for MDS, ICUS or AML according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for MDS, ICUS or AML 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.