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Stem Cell Harvest Trial

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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

Imatinib. 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,

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

Email: nichols@...

Profile Page: Columbia University Medical Center, New York, NY

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