PHASE I-II MULTICENTER STUDY OF P210-B2A2 DERIVED PEPTIDE VACCINE IN CHRONIC MYELOID LEUKEMIA PATIENTS IN COMPLETE CYTOGENETIC RESPONSE WITH PERSISTENT MOLECULAR RESIDUAL DISEASE DURING IMATINIB TREATMENT
- Conditions
- Chronic myeloid leukemia
- Registration Number
- EUCTR2008-001107-27-DE
- Lead Sponsor
- niversität Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
-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
-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
- Secondary Outcome Measures
Name Time Method