A Phase II Study of Gleevec and Arsenic Trioxide in Patients With CML Who Fail Gleevec

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

1.0 OBJECTIVES 1.1 To test the activity of arsenic trioxide in combination with imatinib in patients with CML with cytogenetic evidence of residual disease.

1.2 To determine the toxicity associated with this therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Mexico Cancer Care Alliance
• Treatments: Arsenic Trioxide; Imatinib Mesylate

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.