E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
•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) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |