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Trial Information
Summary: Peripheral Blood Stem Cell Mobilization and Storage in Patients with Chronic Myelogenous Leukemia in Complete Cytogenetic Remission on Imatinib.
This is a study to see the safety and feasibility of harvesting
peripheral blood stem cells from patients with CML in complete
cytogenetic remission on Imatiinib. Peripheral blood stem cells in
remission can be collected, frozen and stored for future use for
autologous transplantation, should the CML become resistant to
Imatinib, or show signs of acceleration. Imatinib will be
temporarily discontinued. Filgrastim (G-CSF) will be given to
stimulate stem cells, and an apheresis catheter inserted. Up to
five days of pheresis will be undertaken to get adequate numbers of
stem cells. Percentage of Philadelphia chromosome will be checked
pre- and post-harvest. After harvesting patients will resume
Imatinib and return to the care of their primary oncologist.
Study Criteria:
- CML in complete cytogenetic remission as measured by bone
marrow evaluation within 1 month.
- On Imatinib greater than 3 months.
- Age >18.
- Adequate organ function for transplantation.
- HIV negative.
- Patients must either not be eligible or currently refusing
allogeneic stem cell transplantation.
- Marrow myelofibrosis < 3+.
For more information,
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Contact:
Gwen L. Nichols, M.D., Principal Investigator
Columbia University Medical Center
650 W. 168th St., BB 20-08
New York, NY 10032
Telephone: 212-305-5705
Fax: 212-305-7348
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Trial listings updated: June 1, 2008 at 5:44:56 AM
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