A Phase II Study of Gleevec and Arsenic Trioxide in Patients With CML Who Fail to Achieve a Complete Response to Initial Gleevec Treatment

Inclusion Criteria

Inclusion criteria:

- All patients, 18 years of age or older, with a diagnosis of CML.

- Patients must have a life expectancy of at least 12 weeks.

- Patients must have an ECOG performance status of 0-2.

- Patients must sign an informed consent.

- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and
SGOT or SGPT < two times the upper limit of normal, and adequate renal function as
defined by a serum creatinine < 1.5 x upper limit of normal.

- Patients with CML in chronic phase on gleevec as first line therapy who fulfill the
following criteria:

- Failure to achieve a complete hematologic response (CHR) after 3 months of therapy
(hematologic resistance)

- Failure to achieve a complete cytogenetic response (CGCR) after > 9 months of
therapy.

- Cytogenetic relapse, defined as an increase in the Ph+ cells by at least 30%.

- Hematologic relapse defined as the appearance of any of the following, confirmed by a
second determination > 1 month later:

- WBC count >20, 000,

- Platelet count >600,000,

- Progressive splenomegaly > 5 cm below the left intercostals margin,

- >5% myelocytes and/or metamyelocytes in the peripheral blood,

- Blasts or promyelocytes in the peripheral blood

Exclusion Criteria:

- Pregnant women or nursing mothers are not eligible for this trial. Patients of child
bearing potential must use adequate contraception.

- Patients may receive no other concurrent chemotherapy or radiation therapy during
this trial.

- Patients with severe medical problems such as uncontrolled diabetes mellitus or
cardiovascular disease or active infections are not eligible for this trial.