Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease
Condition: Chronic Myeloid Leukemia; Minimal Residual Disease
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neoplasm, Residual
Intervention: Synthetic Tumor-Specific Breakpoint Peptide Vaccine
Intervention description: CML vaccine, Imatinib mesylate, subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, then monthly for 10 months
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Myeloid Leukemia; Minimal Residual Disease; Peptide Vaccine

Summary:

      The goal of this clinical research study is to learn if giving 1 of 2 CML (Chronic Myeloid
      Leukemia) vaccines (CML-VAX B2 or CML-VAX B3) together with imatinib mesylate can decrease or
      eliminate all evidence of disease in patients who have CML that is in remission after
      treatment with imatinib mesylate, but who still have small amounts of detectable disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with Ph chromosome positive or BCR-ABL-positive CML (as determined by
             cytogenetics, FISH, or RT-PCR).

          2. Patients must have reached their 18th birthday.

          3. 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.

          4. Patients must be in complete cytogenetic remission confirmed by two marrows, the
             second being at least one month after the first.

          5. 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.

          6. Karnofsky performance status should be > 70.

          7. Adequate organ function defined as: bilirubin <2x upper limit of normal (ULN),
             creatinine <1.5x ULN, and ALT and AST <2.5x ULN.

          8. All patients must be informed of the investigational nature of this study and must
             sign and give written informed consent in accordance with institutional and federal
             guidelines.

          9. Women of childbearing potential (i.e., not post-menopausal 24 months or not surgically
             sterile) must agree to use effective methods of contraception.

        Exclusion Criteria:

          1. Patients with a history of accelerated or blast crisis. Accelerated phase is defined
             as 15 to 30% blasts or >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.

          2. Patients with autoimmune disorders or known immune deficiency.

          3. Patients receiving immunosuppressive therapy, corticosteroids, chemotherapy, or
             therapy for CML other than imatinib.

          4. Patients receiving any other investigational agents.

          5. Patients who are pregnant or breast-feeding.

          6. 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.

          7. Patients who have undergone major surgery within 28 days before registration, or who
             have not fully recovered from any other prior major surgery.

          8. Patients who have undergone stem cell transplantation.

          9. Patients who have received radiation therapy within 4 weeks of enrollment.