Leukapheresis using Amicus Separator

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-001103
    • Scottsdale/Phoenix, Arizona: 16-001103
    Sponsor Protocol Number: 16-001103

About this study

The study is being done to determine if the device being used in this study, the Amicus apheresis device can perform effective leukapheresis procedures and be used instead of the COBE Spectra when it is no longer available.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Patients will have presumed diagnosis of one of the following:
    • AML (Acute Myelogenous Leukemia) FAB classification M0, M1, M2, M3, M4, M5, M6, M7;
    • ALL (Acute Lymphocytic Leukemia);
    • CLL (Chronic Lymphocytic Leukemia);
    • CML (Chronic Myelogenous Leukemia).
  • Age 18 years old and older.

Exclusion Criteria:

  • Unstable blood pressure, electrolytes imbalance with clinical consequences. 
  • Known pregnancy. 
  • Age < 18 years.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jeffrey Winters, M.D.

Open for enrollment

Contact information:

Page McCarthy

(507)266-1294

McCarthy.Page@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jeffrey Winters, M.D.

Closed for enrollment

Contact information:

Page Abdelaty

(507)266-1294

Abdelaty.Page@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20304181

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