Connect® MDS/AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
18 Years
N/A
Both
Myelodysplastic Syndromes, Acute Myeloid Leukemia
Trial Information
Connect® MDS/AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
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.
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
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- MDS patients must be at least 18 years of age at the time of informed consent
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- 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:
- Diagnosis of acute promyelocytic leukemia (APL)
- Diagnosis of MDS or AML rejected by Central Eligibility Review
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Patient Demographics
Outcome Description:
Describe demographics, baseline characteristics and clinical outcomes of the patients with LR or HR MDS, MDS risk not determined, and AML.
Outcome Time Frame:
Up to 8 years
Safety Issue:
No
Principal Investigator
Oleg Zernovak, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Celgene Corporation
Authority:
United States: Institutional Review Board
Study ID:
Connect® MDS/AML Registry
NCT ID:
NCT01688011
Start Date:
August 2013
Completion Date:
August 2021
Related Keywords:
- Myelodysplastic Syndromes
- Acute Myeloid Leukemia
- Myelodysplastic Syndromes
- MDS
- Acute Myeloid Leukemia
- AML
- Registry
- Connect®
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Myelodysplastic Syndromes
- Preleukemia
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