Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    connect MDS/AML
Previous Study | Return to List | Next Study

Connect® Myeloid Disease Registry

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.
 
ClinicalTrials.gov Identifier: NCT01688011
Recruitment Status : Recruiting
First Posted : September 19, 2012
Last Update Posted : April 1, 2021
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 1, 2021
Study Start Date December 12, 2013
Estimated Primary Completion Date March 31, 2031   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 30, 2021)
  • Patient Demographics- MDS/AML/ICUS Cohorts [ Time Frame: Up to 8 years ]
    Describe demographics, baseline characteristics and clinical outcomes of the patients with LR or HR MDS, ICUS, and AML.
  • Diagnostic and Treatment Patterns- MDS/AML/ICUS Cohorts [ 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- MDS/AML/ICUS Cohorts [ 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- MF Cohort [ Time Frame: Up to 5 years ]
    Describe demographics, baseline characteristics, patient recorded outcomes, and clinical outcomes of patients enrolled to the MF cohort
  • Diagnostic and Treatment Patterns- MF Cohort [ Time Frame: Up to 5 years ]
    Describe current and evolving patterns for diagnosis, treatment sequencing, routine clinical practice patterns and clinical outcome measures in patients enrolled in the MF Cohort
  • Safety and Effectiveness- MF Cohort [ Time Frame: Up to 5 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
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® Myeloid Disease Registry
Official Title Connect® Myeloid: The Myelofibrosis (MF), Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
Brief Summary The purpose of the Connect® Myeloid disease registry is to provide unique insights into treatment decisions and treatment patterns as they relate to clinical outcomes of patients with myeloid diseases in routine clinical practice. This disease registry will also evaluate molecular and cellular markers that may provide further prognostic classification which may or may not be predictive of therapy and clinical outcomes.
Detailed Description This Disease Registry will collect data on patient characteristics, treatment patterns and clinical outcomes. The objective is to describe how patients with myeloid diseases are treated; and to build a knowledge base regarding the effectiveness and safety of first line and subsequent treatment regimens in both community and academic settings. Enrolled patients will receive treatment and evaluations for their disease according to the standard of care and routine clinical practice at each study site. All treatments that patients receive for their disease 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 2,100 patients across approximately 150-200 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
  • Primary Myelofibrosis
  • Myelodysplastic Syndromes
  • Leukemia, Myeloid, Acute
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).
  • Myelofibrosis (MF)
    Newly treated MF patients receiving treatment for MF or MF-related cytopenias. This cohort also includes patients with myelodysplastic syndrome (MDS)/myeloproliferative neoplasm (MPN) overlap syndromes, excluding juvenile myelomonocytic leukemia (JMML).
  • Idiopathic cytopenia of undetermined significance (ICUS)
    Newly diagnosed ICUS patients.
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: March 30, 2021)
2900
Original Estimated Enrollment
 (submitted: September 14, 2012)
1500
Estimated Study Completion Date March 31, 2031
Estimated Primary Completion Date March 31, 2031   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients must be able to provide written informed consent form (ICF)
  • Must be willing and able to complete baseline and follow-up HRQoL instruments, for which patients must be proficient in either English or Spanish
  • AML patients must be at least 55 years of age at the time of informed consent.
  • MF, ICUS, and MDS patients must be at least 18 years of age at the time of informed consent.

Idiopathic Cytopenias of Undetermined Significance (ICUS), Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML) patients:

  • Newly diagnosed primary or secondary disease. To be considered "newly diagnosed", a patient's confirmed diagnosis must be made no more than 60 days prior to the date of consent signature. (An additional 5-day window [i.e., up to 65 days prior to the date of ICF signature] may be allowed in special circumstance upon sponsor approval)
  • Cohort assignment confirmed by central eligibility review. Cohort assignment must also be confirmed by the site.

Myelofibrosis (MF) patients:

  • Patients who initiated their first active systemic treatment for MF and/or MF-related cytopenias within 60 days prior to the date of consent signature. This cohort allows the enrollment of subjects with a diagnosis of Myelodysplastic/Myeloproliferative overlap syndromes (MDS/MPN overlap syndrome).
  • Cohort assignment is confirmed by the site. Central eligibility review is not required.

Exclusion Criteria:

  • Suspected or proven acute promyelocytic leukemia (APL) (FAB M3 or WHO 2008) based on morphology, immunophenotype, molecular assay or karyotype
  • Currently enrolled in any interventional clinical trial where the patient is being treated with an investigational product that cannot be identified.
  • Idiopathic Cytopenias of Undetermined Significance (ICUS), Myelodysplastic Syndromes (MDS) patients who received or are receiving active (disease modifying) therapy for the treatment of MDS prior to the date of informed consent.
  • Acute Myeloid Leukemia (AML) patients who initiated active (disease modifying treatment for AML more than 2 weeks prior to the date of consent.
  • Myelodysplastic/Myeloproliferative (MDS/MPN) overlap syndrome patients with suspected or proven excluding juvenile myelomonocytic leukemia.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kate Anderton 803-493-4276 connectmdsamlregistry@bms.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: Irene Sheng DeGutis, PharmD, RPh Celgene Corporation
PRS Account Celgene
Verification Date March 2021