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Connect® MDS/AML Disease Registry

This study is currently recruiting participants.
Verified November 2017 by Celgene
Sponsor:
ClinicalTrials.gov Identifier:
NCT01688011
First Posted: September 19, 2012
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene
September 14, 2012
September 19, 2012
November 6, 2017
December 12, 2013
December 12, 2018   (Final data collection date for primary outcome measure)
  • Patient Demographics [ Time Frame: Up to 8 years ]
    Describe patient demographics and clinical outcomes of patients with LR or HR MDS, ICUS, and AML
  • Diagnostic and Treatment Patterns [ Time Frame: Up to 8 years ]
    Describe current and evolving patterns for diagnosis, treatment sequencing, routine clinical practice patterns and clinical outcome measures in patients with LR or HR MDS, ICUS, and AML
  • Safety and Effectiveness [ Time Frame: Up to 8 years ]
    Describe the survival status, clinical response to treatment, select laboratory results, occurrence of secondary primary malignancies, deaths, select adverse events.
  • Patient Demographics [ Time Frame: Up to 8 years ]
    Patient Demographics
  • Diagnostic and Treatment Patterns [ Time Frame: Up to 8 years ]
    Diagnostic and Treatment Patterns
Complete list of historical versions of study NCT01688011 on ClinicalTrials.gov Archive Site
  • Patient Reported Outcome [ Time Frame: Up to 8 years ]
    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 ]
    Perform molecular and cellular correlative studies on blood/bone marrow and oral epithelial cell samples.
  • Patient Reported Outcome Measure [ Time Frame: Up to 8 years ]
    Analyze 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 Outcome Measure [ Time Frame: Up to 8 years ]
    Perform molecular and cellular correlative studies on collected blood/bone marrow samples.
Not Provided
Not Provided
 
Connect® MDS/AML Disease Registry
Connect® MDS/AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (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, ICUS 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.
This Disease Registry will collect data on patient characteristics, treatment patterns and clinical outcomes. The objective is to describe how newly diagnosed MDS, ICUS 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, ICUS or AML according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for MDS, ICUS 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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Perform molecular and cellular correlative studies on blood/bone marrow and oral epithelial cell samples.
Non-Probability Sample
Approximately 1,500 patients across approximately 150 sites throughout the US will be enrolled in the Connect® MDS and AML Registry. Sites will include both community-based and academic centers that are representative of where patients with MDS and AML are diagnosed and treated. To best capture the distribution of sites with regard to the settings of where MDS and AML patients are typically treated in routine practice, approximately 70-80% of the sites will be community hematology/ oncology clinics and approximately 20-30% will be academic-based institutions.
  • Myelodysplastic Syndromes
  • Acute Myeloid Leukemia
Not Provided
  • 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).
  • Idiopathic Cytopenia of Undetermined Significance (ICUS)
    Newly diagnosed ICUS patients as determined by clinical criteria defined by Valent et al.
Steensma DP, Abedi M, Bejar R, Cogle CR, Foucar K, Garcia-Manero G, George TI, Grinblatt D, Komrokji R, Ma X, Maciejewski J, Pollyea DA, Savona MR, Scott B, Sekeres MA, Thompson MA, Swern AS, Nifenecker M, Sugrue MM, Erba H. Connect MDS/AML: design of the myelodysplastic syndromes and acute myeloid leukemia disease registry, a prospective observational cohort study. BMC Cancer. 2016 Aug 19;16:652. doi: 10.1186/s12885-016-2710-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
December 12, 2026
December 12, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must be able to provide written informed consent
  • Newly diagnosed (confirmed diagnosis within 60 days prior to date of informed consent signature), primary or secondary Myelodysplastic Syndromes (MDS), or Acute Myeloid Leukemia (AML), or Idiopathic Cytopenia of Undetermined Significance (ICUS)
  • Disease diagnosis confirmed by Central Eligibility Review
  • AML patients must be at least 55 years of age at the time of informed consent signature
  • MDS/ICUS 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:

  • Suspected or proven acute promyelocytic leukemia (APL) (FAB M3 or WHO 2008) based on morphology, immunophenotype, molecular assay or karyotype
  • MDS, AML or ICUS cohort assignment by Central Eligibility Review is not confirmed by site
  • For MDS and ICUS patients: receiving active (disease modifying) treatment** prior to ICF date (Supportive care such as transfusions, antibiotics, iron chelators, EPO, growth factors (G-CSF/GM-CSF) is allowed)
  • For AML patients: receiving active (disease modifying) treatment** that had been initiated for more than 2 weeks (14 days) prior to ICF date (Supportive care, such as, transfusions, antibiotics, iron chelators, EPO, growth factors (G-CSF/GM-CSF), tumor lysis prophylaxis allowed)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Melissa Nifenecker 908-219-0809 connectmdsaml-registry@celgene.com
Puerto Rico,   United States
 
 
NCT01688011
Connect® MDS/AML Registry
No
Not Provided
Not Provided
Celgene
Celgene
Not Provided
Study Director: Han Myint, MD Celgene Corporation
Celgene
November 2017