This study assessed the safety of a multipeptide vaccine targeting the Bcr-abl fusion protein, given with a cytokine gene adjuvant, in patients with Philadelphia chromosome-positive chronic myeloid leukaemia. Participants had received imatinib for at least 12 months and were in first complete haematological response. It was carried out as a Phase 1 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Patients with Philadelphia chromosome positive CML who are: 1. of subtype b3a2 2. In first complete hematologic response; 3. have received imatinib for \> 12 months of which the last 3 months were at a stable dose of at least 400 mg/day; 4. have PCR detectable BCR-ABL transcript by qRT-PCR, and 5. with persistent disease, as defined by \<1 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared with a standardized baseline. * Greater than or equal to 18 years in age * No known infection with human immunodeficiency virus * Physician and patient willingness to maintain the baseline dose of imatinib throughout the study period * Written informed consent obtained from the patient Exclusion Criteria: * Female patients who are pregnant or breast feeding or adults of childbearing age who are not using adequate birth control. * Current use of systemic immunosuppressive medications * ALT or AST \>3X Upper limit Normal * Prior allogeneic stem cell transplantation * Other experimental therapy within the past two months * Prior participation in vaccine studies within the past six months * Oxygen saturation of less than 95% at room air * History of recent acute myocardial infarction, unstable angina, or pulmonary decompensation requiring hospitalization within the past 3 months. * Concurrent and or uncontrolled psychiatric or medical condition which may interfere with the study completion.