Chronic myeloid leukemia
Conditions
Interventions
Product Code: CMLVAXb2a2-25
Pharmaceutical Form: Powder for injection*
Sponsors
Universität Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years - Diagnosis of CML with b2a2 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). - ECOG performance score of 0 or 1 - Total bilirubin = 2x upper limit of normal - AST and ALT = 2.5x upper limit of normal - Creatinine = 1.5x upper limit of normal - Adequate cardiac function - 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 feasibility of vaccinations with a p210-b2a2 derived peptide (CMLVAXb2a2-25) in b2a2-CML patients with molecularly detectable residual disease persisting after at least 18 months of imatinib treatment;Secondary Objective: •response after the 9th month •in vivo and in vitro peptide-specific immune response induced by the vaccinations after immunization phase (evaluation at 3 months), reinforcement phase (evaluation at 6 months) and maintenance phase •the reduction of peripheral blood BCR-ABL/ABL ratio of individual prevaccine levels following vaccinations with CMLVAXb2a2-25. The response to CMLVAXb2a2-25 is defined as reduction by at least 50% of the peripheral blood BCR-ABL/ABL ratio after immunization and reinforcement boosts of vaccine and confirmation after 10° vaccinations •the reduction of molecular residual disease observed after immunization •the reduction of molecular residual disease observed after 2 maintenance three-monthly boosts of vaccine •the rate of complete molecular response observed at any time after immunization (BCR-ABL/ABL ratio 0,001 and/or negative Nested PCR);Primary end point(s): The primary endpoint of the trial is to assess the rate of patients able to continue the vaccinations after the 9th month (defined as rate of patients who showed a reduction of at least 50% of the peripheral blood BCR-ABL/ABL ratio compared to the individual prevaccine levels and who did not discontinue the treatment during the 9 months because of toxicity) | — |
Countries
Germany
Outcome results
None listed