Connect MDS/AML Disease Registry

  • STATUS
    Recruiting
  • End date
    Dec 12, 2030
  • participants needed
    2100
  • sponsor
    Celgene
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Updated on 5 November 2020
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Investigator
Melissa Nifenecker
Primary Contact
UM St. Joseph's Medical Center (9.3 mi away) Contact
+223 other location
myeloid leukemia
myelodysplastic syndromes
leukemia
bone marrow procedure

Summary

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.

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.

Details
Clinical Study IdentifierNCT01688011
SponsorCelgene
Last Modified on5 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Bone marrow disorder or MYELODYSPLASTIC SYNDROME or Preleukemia or Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML) or Acute myeloi...?
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)
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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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