Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

Primary Myelofibrosis Myelodysplastic Syndromes Leukemia, Myeloid, Acute MDS Acute myeloid leukemia AML Registry Connect® ICUS Idiopathic Cytopenias of Undetermined Significance Myelofibrosis MF Myelodysplastic/Myeloproliferative overlap syndromes MDS/MPN overlap syndromes Leukemia Preleukemia Leukemia, Myeloid Syndrome Lower-Risk Myelodysplastic Syndromes (LR MDS) Higher-Risk Myelodysplastic Syndromes (HR MDS) Acute Myeloid Leukemia (AML) Myelofibrosis (MF) Idiopathic cytopenia of undetermined significance (ICUS)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSD Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • VA Central California Health Care System accepting new patients
    Fresno California 93703-2223 United States
  • Robert A. Moss, M.D.,F AC.P, Inc withdrawn
    Fountain Valley California 92708 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT01688011
Study Type
Observational
Last Updated