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 - GIMEMA CML0206

• Conditions: CHRONIC MYELOID LEUKEMIA; MedDRA version: 9.1Level: LLTClassification code 10009013Term: Chronic myeloid leukaemia

• Registration Number: EUCTR2006-006189-40-IT
• Lead Sponsor: G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL ADULTO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-04
• Last Update Posted: 23 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 69

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 .