| Inclusion Criteria: | 1) Patients with CML in chronic phase who have failed to achieve or have lost an adequate response to IM. For the purpose of this trial this will be defined as a lack of any cytogenetic response after 6 months of therapy or lack of major cytogenetic response after 12 months of therapy with IM. Patients that have lost their major or complete cytogenetic response will also be eligible. Patients who show a sustained increase in BCR-ABL/ABL ratio of >/= 1-log confirmed in at least two consecutive PCR analyses (at least one month apart from each other) will also be eligible.
2) *continued from above: Patients with stable molecular response defined as 2 consecutive PCR-positive results (no more than 1/2 log improvement) will also be eligible. Patients must be taking stable dose of IM for at least 3 months before study enrollment, and recovered from all toxicities related to IM, to grade 0-1.
3) Patients should be in complete or partial hematological remission, including WBC </=20 x 10(9)/L, and platelets </= 600 x 10(9)/L.
4) ECOG scale performance status of 2 or less.
5) Age greater than 18 years of age since disease is extremely rare in younger age groups.
6) Adequate liver (total bilirubin of less than 2 x and AST or ALT of less than 2 x upper limits of normal), and renal function (creatinine of less than 2 x upper limit of normal).
7) Signed informed consent form.
8) Negative pregnancy test in women of childbearing age.
9) Negative hepatitis B and C screening blood tests. |