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Connect® Myeloid Disease Registry

Status
Active
Cancer Type
Cancer-Related Syndrome
Leukemia
Myelodysplastic Syndromes (MDS)
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
Other
NCT ID
NCT01688011
Protocol IDs
Connect® MDS/AML Registry (primary)
Study Sponsor
Celgene

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.

Objectives

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.

Eligibility

  1. Patients must be able to provide written informed consent form (ICF)
  2. Must be willing and able to complete baseline and follow-up HRQoL instruments, for which patients must be proficient in either English or Spanish
  3. AML patients must be at least 55 years of age at the time of informed consent.
  4. MF, ICUS, and MDS patients must be at least 18 years of age at the time of informed consent. Newly diagnosed Idiopathic Cytopenias of Undetermined Significance (ICUS), Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML) patients:
  5. 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)
  6. Cohort assignment confirmed by central eligibility review. Cohort assignment must also be confirmed by the site. Myelofibrosis (MF) patients:
  7. Patients who initiated their first active systemic treatment for MF and/or MF-related cytopenias within 90 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).
  8. Cohort assignment is confirmed by the site. Central eligibility review is not required. Treated Lower-Risk Myelodysplastic Syndromes (LR-MDS) patients:
  9. Patients who have initiated first active treatment regimen containing at least one non-ESA therapy, within 90 days prior to ICF
  10. Cohort assignment is confirmed by site. Central eligibility review is not required.

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Austell


1700 Hospital South Drive
Suite 300
Austell, GA 30106
770-281-5131
www.ngoc.com

Doctors:

Sujatha Hariharan MD
Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen


200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton


157 Clinic Avenue
Suite 101
Carrollton, GA 30117
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD
Randall E. Pierce MD

Northwest Georgia Oncology Centers - Cartersville


100 Market Place Boulevard
Suite 200
Cartersville, GA 30121
770-281-5131
www.ngoc.com

Doctors:

Satyen R. Mehta MD
Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville


6002 Professional Parkway
Suite 220
Douglasville, GA 30134
770-281-5131
www.ngoc.com

Doctors:

Navin P. Wadehra MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Jasper


1020 J.L. White Drive
Suite 160
Jasper, GA 30143
770-281-5131
www.ngoc.com

Doctors:

Curtis R. Miles MD

Northwest Georgia Oncology Centers - Paulding


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Doctors:

Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Villa Rica


705 Dallas Highway
Suite 204
Villa Rica, GA 30180
770-281-5131
www.ngoc.com

Doctors:

Randall E. Pierce MD
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