Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

Overview

  • Study type

    Interventional
  • Study phase

    III
  • 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.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 1765-00
    • Jacksonville, Florida: 1765-00
    NCT ID: NCT00785525
    Sponsor Protocol Number: NMDP-1

About this study

The purpose of the study is to: - Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from National Marrow Donor Program donors (NMDP) donors - Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis - Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients - Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors

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:

  • PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in NMDP Standards and the Donor Center Manual of Operations.

Exclusion Criteria:

  • Pregnancy or uninterruptible breastfeeding. Pregnancy is an absolute contraindication under this protocol. Women who are breastfeeding must be willing and able to interrupt breastfeeding during the administration of filgrastim and for two days following the final dose.
  • Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
  • History of autoimmune disorders, including rheumatic diseases and thyroid disorders. Exception: As with bone marrow donations, donors with a history of thyroid disease who have undergone successful therapy may be suitable.
  • History of deep vein thrombosis or pulmonary embolism.
  • History of iritis or episcleritis.
  • Thrombocytopenia < 150 x 10(9)/L (< 150,000/µL) at baseline evaluation.
  • Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been fully evaluated.
  • Positive Hemoglobin-Solubility (e.g., SickleDex™ or equivalent) test.
  • Donors receiving experimental therapy or investigational agents.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Vivek Roy, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Vivek Roy, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015