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Connect® MDS/AML Disease Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01688011
First received: September 14, 2012
Last updated: April 18, 2016
Last verified: April 2016
  Purpose
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.

Condition
Myelodysplastic Syndromes
Acute Myeloid Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Connect® MDS/AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Patient Demographics [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
    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 ] [ 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, ICUS, 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.


Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 1500
Study Start Date: December 2013
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688011

Contacts
Contact: Melissa Nifenecker 908-219-0809 connectmdsaml-registry@celgene.com

  Show 167 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Mary Sugrue, MD, PhD Celgene Corporation
  More Information

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01688011     History of Changes
Other Study ID Numbers: Connect® MDS/AML Registry 
Study First Received: September 14, 2012
Last Updated: April 18, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Celgene Corporation:
Myelodysplastic Syndromes
MDS
Acute Myeloid Leukemia
AML
Registry
Connect®

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Leukemia
Syndrome
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on July 28, 2016