Connect® MDS/AML Disease Registry

Brief Title

Connect® MDS/AML Disease Registry

Official Title

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

Brief Summary

      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.
    

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 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 or AML according to the standard of care and
      routine clinical practice at each study site. All treatments that patients receive for MDS 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.
    

Study Type

Observational

Primary Outcome

Patient Demographics

Secondary Outcome

 Patient Reported Outcome

Condition

Myelodysplastic Syndromes

Study Arms / Comparison Groups

 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

2100

Start Date

December 12, 2013

Completion Date

December 12, 2030

Primary Completion Date

December 12, 2022

Eligibility Criteria

        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)

          -  Disease diagnosis 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:

          -  For MDS and ICUS patients: received/receiving active (disease modifying) therapy** for
             the treatment of MDS and ICUS prior to ICF date (Supportive care such as transfusions,
             antibiotics, iron chelators, EPO, growth factors (G-CSF/GM-CSF) is allowed)

          -  For AML patients: received/receiving active (disease modifying) therapy** for the
             treatment of AML. Patients who initiated treatment for AML within 2 weeks (14 days)
             prior to ICF date are eligible for the registry if all other eligibility criteria are
             met (Supportive care, such as, transfusions, antibiotics, iron chelators, EPO, growth
             factors (G-CSF/GM-CSF), tumor lysis prophylaxis is allowed)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Irene Sheng DeGutis, PharmD, RPh, 908-219-0809, [email protected]

Location Countries

Puerto Rico

Location Countries

Puerto Rico

NCT ID

NCT01688011

Organization ID

Connect® MDS/AML Registry

Responsible Party

Sponsor

Study Sponsor

Celgene

Study Sponsor

Irene Sheng DeGutis, PharmD, RPh, Study Director, Bristol-Myers Squibb

Verification Date

October 2020