CHRONIC MYELOID LEUKEMIA MedDRA version: 9.1 Level: LLT Classification code 10009013 Term: Chronic myeloid leukaemia
Conditions
Interventions
Product Code: CMLVAX100
Pharmaceutical Form: Concentrate for solution for injection
Current Sponsor code: CMLVAX100
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number:
Sponsors
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL ADULTO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of CML with b3a2 breakpoint - Conventional treatment with imatinib for a minimum of 18 months - Complete cytogenetic response documented al least in 2 different examinations - Persistence of molecularly detectable residual disease any level of bcr-abl transcript . - WHO performance score of 0 or 1 - Total bilirubin 8804; 2x upper limit of normal - AST and ALT 8804; 2.5x upper limit of normal - Creatinine 8804; 1.5x upper limit of normal - Female patients of childbearing potential must agree to use contraception during the study - Provide written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Severe active infection or other serious medical illness that would prevent study completion - Current use of immune suppression or systemic immunosuppressive medication or autoimmune disorders - Patients who have a known immunodeficiency - Current use of investigational products - Pregnant or lactating women - Patients who cannot provide or are not willing to provide an informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to evaluate the activity of p210-derived peptides vaccinations in terms of BCR-ABL/ ABL ratio reduction at 6 months from the starting of the vaccination program.;Secondary Objective: - to determine the entity of reduction of molecular residual disease observed after immunization; - to determine the entity of reduction of molecular residual disease observed after 2 maintenance three-monthly boosts of vaccine - to determine the rate of complete molecular response observed at any time after immunization; - to determine in vivo and in vitro peptide-specific immune response induced by the vaccinations.;Primary end point(s): To assess the rate of response patients showing a reduction by at least 50 of the peripheral blood BCR-ABL/ABL ratio compared to the individual prevaccine levels at the evaluation after 6th months after immunization and reinforcement boosts persisting at the 9th month after 10th vaccination . | — |
Countries
Italy
Outcome results
None listed