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Prepublished online as a Blood First Edition Paper on September 22, 2003; DOI 10.1182/blood-2003-03-0954.

Submitted March 27, 2003
Accepted August 17, 2003
A multivalent bcr-abl fusion peptide vaccination trial in patients with chronic myeloid leukemia
Kathleen Cathcart, Javier Pinilla-Ibarz, Tatyana Korontsvit, Joseph Schwartz, Victoriya Zakhaleva, Esperanza B Papadopoulus, and David A Scheinberg*
Department of Medicine and Molecular Pharmacology and Chemistry, Memorial Sloan Kettering Cancer Center, New York, NY, USA
* Corresponding author; email: d-scheinberg{at}ski.mskcc.org.
A tumor specific, bcr-abl derived fusion peptide vaccine can be safely administered to patients with CML and can elicit a bcr-abl peptide specific T cell immune response (Blood 95: 1781, 2000). In the present phase II trial, 14 patients with CML in chronic phase were vaccinated with 6 fusion peptides mixed with QS-21. No significant toxic effects were observed. Fourteen of 14 patients had DTH and/or CD4 proliferative responses develop after beginning vaccinations, and 11 of 14 patients showed gamma-IFN release by CD4 ELISPOT at one or more timepoints. These responses were CD4/CD45RO+. A peptide specific CD8+ interferon gamma ELISPOT was found in 4 patients. Four patients in hematologic remission had a decrease in Ph percentage (three concurrently receiving alpha-interferon and one on Imatinib), and three patients in molecular relapse after allogenic transplant became transiently PCR negative after vaccination; two of these patients received concurrent DLI. All 5 patients on IFN ultimately reached a complete cytogenetic remission. In conclusion, a tumor-specific bcr-abl breakpoint peptide-derived vaccine can be safely administered and can reliably elicit measurable peptide specific CD4 immune responses, including in patients post bone marrow transplantation, on interferon or on Imatinib. A relationship between the clinical responses and vaccination cannot be determined from this trial.

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