Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia

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Trial Identification

Brief Title: Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia

Official Title: 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

Study ID: NCT00466726

Conditions

Leukemia

Interventions

bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine

sargramostim

Study Description

Brief Summary: RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with Philadelphia chromosome-positive chronic myelogenous leukemia.

Detailed Description: OBJECTIVES: Primary * 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. Secondary * 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.