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.
Recruitment Information
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
Administrative Informations
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