Connect® MDS/AML Disease Registry
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.
Acute Myeloid Leukemia
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Connect® MDS/AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry|
- Patient Demographics [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]Describe demographics, baseline characteristics and clinical outcomes of the patients with LR or HR MDS, MDS risk not determined, and AML.
- Diagnostic and Treatment Patterns [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]Describe current and evolving patterns for diagnosis, treatment sequencing, routine clinical practice patterns and clinical outcome measures in patients with LR or HR MDS, MDS risk not determined, and AML
- Safety and Effectiveness [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]Describe the survival status, clinical response to treatment, select laboratory results, occurrence of secondary primary malignancies, deaths, select adverse events.
- Patient Reported Outcome [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]Summarize patient reported outcomes (including e.g., Health-Related Quality of Life (HRQOL)) and economic outcomes, and their association with patient characteristics, treatment regimens, and clinical outcomes
- Correlative Studies [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]Perform molecular and cellular correlative studies on blood/bone marrow and oral epithelial cell samples.
Biospecimen Retention: Samples With DNA
Perform molecular and cellular correlative studies on blood/bone marrow and oral epithelial cell samples.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2021|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
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).
Newly diagnosed unknown-risk MDS patients as determined by International Prognostic Scoring System (IPSS); defined as not having risk assigned due to unsuccessful cytogenetics after two bone marrow attempts.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01688011
|Contact: Melissa Nifeneckerfirstname.lastname@example.org|
|United States, Florida|
|University Cancer Institute||Recruiting|
|Boynton Beach, Florida, United States, 33426|
|Study Director:||Oleg Zernovak, M.D.||Celgene Corporation|