Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease

Inclusion Criteria

• Patients with Ph chromosome positive or BCR-ABL-positive CML (as determined by cytogenetics, FISH, or RT-PCR).
• Patients must have reached their 18th birthday.
• Patients must have received imatinib therapy for at least 12 months and must not have had changes in their dose of imatinib in the last 6 months. Patients must not have had a continuous interruption of imatinib therapy of greater than 14 days or for a total of 6 weeks in the 6 months prior to enrollment.
• Patients must be in complete cytogenetic remission confirmed by two marrows, the second being at least one month after the first.
• Patients must have detectable BCR-ABL transcript levels that are not more than 0.5-log lower than the lowest value obtained in the last 6 months, with at least two values obtained during this period.
• Karnofsky performance status should be > 70.
• Adequate organ function defined as: bilirubin 30% blasts plus promyelocytes in the peripheral blood or marrow, >20% basophils, or platelets <100 x 10^9/L, unrelated to therapy. Cytogenetic abnormalities in addition to the Ph chromosome are not considered a defining feature of accelerated phase.
• Patients with autoimmune disorders or known immune deficiency.
• Patients receiving immunosuppressive therapy, corticosteroids, chemotherapy, or therapy for CML other than imatinib.
• Patients receiving any other investigational agents.
• Patients who are pregnant or breast-feeding.
• Patients with clinically significant heart disease (New York Heart Association Class III or IV) or other serious intercurrent illnesses, active uncontrolled infections requiring antibiotics or active bleeding.
• Patients who have undergone major surgery within 28 days before registration, or who have not fully recovered from any other prior major surgery.
• Patients who have undergone stem cell transplantation.
• Patients who have received radiation therapy within 4 weeks of enrollment.