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Connect® MDS/AML Disease Registry

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ClinicalTrials.gov Identifier: NCT01688011
Recruitment Status : Recruiting
First Posted : September 19, 2012
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date September 14, 2012
First Posted Date September 19, 2012
Last Update Posted Date April 18, 2019
Study Start Date December 12, 2013
Estimated Primary Completion Date December 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 10, 2015)
  • 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.
Original Primary Outcome Measures
 (submitted: September 14, 2012)
  • Patient Demographics [ Time Frame: Up to 8 years ]
    Patient Demographics
  • Diagnostic and Treatment Patterns [ Time Frame: Up to 8 years ]
    Diagnostic and Treatment Patterns
Change History Complete list of historical versions of study NCT01688011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 18, 2013)
  • 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.
Original Secondary Outcome Measures
 (submitted: September 14, 2012)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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, 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.
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, 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Perform molecular and cellular correlative studies on blood/bone marrow and oral epithelial cell samples.
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Myelodysplastic Syndromes
  • Acute Myeloid Leukemia
Intervention Not Provided
Study Groups/Cohorts
  • 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. (Valent P, Horny H-P, Bennett JM et al. 2007. Definitions and standards in the diagnosis and treatment of the myelodysplastic syndromes: Consensus statements and report from a working conference. Leukemia Research. 31: 727-736. And further updated Valent P, Bennett JM et al. 2017. Proposed minimal diagnostic criteria for myelodysplastic syndromes (MDS) and potential pre-MDS conditions. Oncotarget. 8(43): 73483-73500.)
Publications * 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.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 14, 2012)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 12, 2028
Estimated Primary Completion Date December 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Melissa Nifenecker 908-219-0809 connectmdsaml-registry@celgene.com
Listed Location Countries Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01688011
Other Study ID Numbers Connect® MDS/AML Registry
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Celgene
Study Sponsor Celgene
Collaborators Not Provided
Investigators
Study Director: Chrystal Louis, MD Celgene Corporation
PRS Account Celgene
Verification Date April 2019