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Connect® MDS/AML Disease Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01688011
First received: September 14, 2012
Last updated: September 19, 2014
Last verified: September 2014
  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 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 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.


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 2021
Estimated Primary Completion Date: December 2016 (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).
Unknown-Risk MDS
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Approximately 1,500 patients across approximately 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.

Criteria

Inclusion Criteria:

  • Patients must be able to provide written informed consent
  • Newly diagnosed (confirmed diagnosis within 60 days prior to enrollment), primary or secondary Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)
  • Cohort assingnment confirmed by Central Eligibility Review
  • MDS patients of unknown-risk must have undergone two (2) bone marrow tests with failed cytogenetics
  • AML patients must be at least 55 years of age at the time of informed consent signature
  • MDS 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 or AML cohort assignment by Central Eligibility Review is not confirmed by site
  • Treatment with active (disease modifying) agents for MDS or AML prior to ICF date. (Supportive care (growth factors, transfusions, etc.) is 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 81 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Oleg Zernovak, M.D. Celgene Corporation
  More Information

No publications provided

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: September 19, 2014
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, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Syndrome
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014