Connect® MDS/AML Disease Registry

Brief Title

Connect® Myeloid Disease Registry

Official Title

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

Brief 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.
    

Detailed Description

      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.
    

Study Type

Observational

Primary Outcome

Patient Demographics- MDS/AML/ICUS Cohorts

Secondary Outcome

 Patient Reported Outcome

Condition

Primary Myelofibrosis

Study Arms / Comparison Groups

 Newly diagnosed Lower-Risk Myelodysplastic Syndromes (LR-MDS)

Description:  Newly diagnosed lower risk MDS patients as determined by International Prognostic Scoring System (IPSS).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Estimated Enrollment

2300

Start Date

December 12, 2013

Completion Date

March 31, 2031

Primary Completion Date

March 31, 2031

Eligibility Criteria

        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.

        Newly diagnosed 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 90 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.

        Treated Lower-Risk Myelodysplastic Syndromes (LR-MDS) patients:

          -  Patients who have initiated first active treatment regimen containing at least one
             non-ESA therapy, within 90 days prior to ICF

          -  Cohort assignment is confirmed by 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.

          -  Myelofibrosis (MF) and Myelodysplastic/Myeloproliferative (MDS/MPN) overlap syndrome
             patients with suspected juvenile myelomonocytic leukemia (JMML).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Bristol-Myers Squibb, 855-907-3286, [email protected]

Location Countries

Puerto Rico

Location Countries

Puerto Rico

NCT ID

NCT01688011

Organization ID

AZA-MDS-006

Secondary IDs

Connect® MDS/AML Registry

Responsible Party

Sponsor

Study Sponsor

Celgene

Study Sponsor

Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

Verification Date

October 2022