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