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Connect® MDS / AML Disease Registry

Trial Status: Active

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.

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)
  • Disease diagnosis 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

  • For MDS and ICUS patients: received/receiving active (disease modifying) therapy** for the treatment of MDS and ICUS prior to ICF date (Supportive care such as transfusions, antibiotics, iron chelators, EPO, growth factors (G-CSF/GM-CSF) is allowed)
  • For AML patients: received/receiving active (disease modifying) therapy** for the treatment of AML. Patients who initiated treatment for AML within 2 weeks (14 days) prior to ICF date are eligible for the registry if all other eligibility criteria are met (Supportive care, such as, transfusions, antibiotics, iron chelators, EPO, growth factors (G-CSF/GM-CSF), tumor lysis prophylaxis is allowed)

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE
Contact: Lauren Salsbury
Phone: 520-694-2624

California

Fresno
VA Central California Fresno Medical Center
Status: ACTIVE
Contact: Margaret Lynne Chase
Phone: 559-225-6100ext4154
San Diego
University of California San Diego
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE
Contact: Birjis G. Akhund
Phone: 631-425-2163

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL

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.

Trial Phase Phase NA

Trial Type Not provided by clinicaltrials.gov

Lead Organization
Celgene

  • Primary ID Connect® MDS/AML Registry
  • Secondary IDs NCI-2015-01815
  • Clinicaltrials.gov ID NCT01688011