Phase II Multicenter Study of P210-B3A2 Derived Peptide Vaccine in Chronic Myeloid Leukemia Patients in Complete Cytogenetic Response With Persistent Molecular Residual Disease During Imatinib Treatment
- Determine the activity of bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine
(CMLVAX100), in terms of peripheral blood bcr-abl/abl ratio reduction, in patients with
Philadelphia chromosome-positive chronic myelogenous leukemia.
- Determine the reduction of molecular residual disease at 3 months in patients treated
with this vaccine.
- Determine the reduction of molecular residual disease at 12 months in patients treated
with maintenance boosts of this vaccine.
- Determine the rate of complete molecular response at any time after vaccination.
- Determine in vivo and in vitro peptide-specific immune response induced by the vaccine.
OUTLINE: This is a prospective, nonrandomized, open-label, multicenter study.
Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1 and 2 and bcr-abl
p210-b3a2 breakpoint-derived pentapeptide vaccine (CMLVAX100) SC on day 2. Treatment repeats
every 2 weeks for 6 courses. Patients then receive CMLVAX100 SC once monthly for 3 months
and then once every 3 months for 6 months (for a total of 1 year). Patients may receive
additional CMLVAX100 SC every 6 months for at least 3 years. Treatment continues in the
absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 69 patients will be accrued for this study.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Response rate at 6 and 9 months
Monica Bocchia, MD
Nouvo Policlinico "LE SCOTTE'