NCT00466726

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine
BIOLOGICAL	sargramostim

Timeline

• Start date: 2007-03-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2007-04-27
• Last updated: 2018-08-28
• Results posted: 2018-08-28

Locations

17 sites across 1 country: Italy