Connect® MDS/AML Disease Registry
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/27/2018 |
Start Date: | December 12, 2013 |
End Date: | December 12, 2028 |
Contact: | Melissa Nifenecker |
Email: | connectmdsaml-registry@celgene.com |
Phone: | 908-219-0809 |
Connect® MDS/AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
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.
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.
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.
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.
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)
We found this trial at
217
sites
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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New York Medical College The College was founded in 1860 by a group of New...
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McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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Atlanta, Georgia 30318
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4950 Essen Ln
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
(225) 767-0847
Mary Bird Perkins Cancer Center - Baton Rouge Mary Bird Perkins Cancer Center (MBPCC) and...
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Berkeley, California 94705
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Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Saint Alphonsus Regional Medical Center Saint Alphonsus Health System is a four-hospital regional, faith-based Catholic...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
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Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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40 South Clay Street
Hinsdale, Illinois 60521
Hinsdale, Illinois 60521
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