Clinical trial · Interventional
Safety Assessment of a Multipeptide-gene Vaccine in CML
Safety Assessment of a Peptide Vaccine Derived From Bcr-abl Along With Cytokine Genes in CML Patients Undergoing Imatinib Treatment
NCT00455221CI-TRIAL-00007047completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary purpose of this study is to evaluate the safety of a peptide-gene vaccine against CML in patients under Imatinib treatment. We will also perform some laboratory tests suggesting biological response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bcr-abl multipeptide vaccine | Biological | — | UNRESOLVED |
| Cytokine gene adjuvant | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Peptide Vaccine
- interventionNames
- Biological: Bcr-abl multipeptide vaccine
- Genetic: Cytokine gene adjuvant
Primary outcomes (1)
- measure
- To assess safety of bcr-abl peptide vaccination in Ph+ or MRD CML patients
- timeFrame
- At enroll in study and 3 months after intervention
Secondary outcomes (1)
- measure
- To measure the development of a molecular response to vaccination as measured by 1 log decrease in qRT-PCR BCR-ABL levels for at least 3 months; To measure the development of immune response following vaccination
- timeFrame
- At enroll in study and 3 months after intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with Philadelphia chromosome positive CML who are: 1. of subtype b3a2 2. In first complete hematologic response; 3. have received imatinib for \> 12 months of which the last 3 months were at a stable dose of at least 400 mg/day; 4. have PCR detectable BCR-ABL transcript by qRT-PCR, and 5. with persistent disease, as defined by \<1 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared with a standardized baseline. * Greater than or equal to 18 years in age * No known infection with human immunodeficiency virus * Physician and patient willingness to maintain the baseline dose of imatinib throughout the study period * Written informed consent obtained from the patient Exclusion Criteria: * Female patients who are pregnant or breast feeding or adults of childbearing age who are not using adequate birth control. * Current use of systemic immunosuppressive medications * ALT or AST \>3X Upper limit Normal * Prior allogeneic stem cell transplantation * Other experimental therapy within the past two months * Prior participation in vaccine studies within the past six months * Oxygen saturation of less than 95% at room air * History of recent acute myocardial infarction, unstable angina, or pulmonary decompensation requiring hospitalization within the past 3 months. * Concurrent and or uncontrolled psychiatric or medical condition which may interfere with the study completion.
References
Publications (0)
Data not yet available
No reference posted for this study.