Title
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
Phase
Phase 2Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'AdultoStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
LeukemiaIntervention/Treatment
bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine sargramostim ...Study Participants
57RATIONALE: 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.
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.
DISEASE CHARACTERISTICS: Diagnosis of chronic myelogenous leukemia (CML) meeting the following criteria: Philadelphia chromosome positive disease b3a2 breakpoint mutation Prior treatment with conventional imatinib mesylate for ≥ 18 months required Complete cytogenetic response documented on ≥ 2 different examinations Persistence of molecularly detectable residual disease (any level of bcr-abl transcript) Patients continue to receive imatinib mesylate at the same dose (conventional treatment) during study treatment PATIENT CHARACTERISTICS: WHO performance status 0-1 Bilirubin ≤ 2 times upper limit of normal (ULN) AST and ALT ≤ 2.5 times ULN Creatinine ≤ 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No severe active infection or other serious medical illness that would preclude study completion No known immunodeficiency No autoimmune disorders PRIOR CONCURRENT THERAPY: No concurrent immunosuppression or systemic immunosuppressive medication No concurrent dose escalation of imatinib mesylate No other concurrent investigational products
| Event Type | Organ System | Event Term | Chronic Myeloid Leukemia (CML) Patients |
|---|
Response rate evaluated after immunization and reinforcement boosts (evaluation after 6 months, ) and persisting at the 9th month (after 10th vaccination)
A significant in vitro b3a2-peptide-specific CD4+ T cell proliferation
