NCT00455221已完成1 期
Safety Assessment of a Peptide Vaccine Derived From Bcr-abl Along With Cytokine Genes in CML Patients Undergoing Imatinib Treatment
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- To assess safety of bcr-abl peptide vaccination in Ph+ or MRD CML patients
研究概览
简要总结
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.
详细描述
- Patients will continue to take their current dose of Imatinib.
- Patients will undergo HLA-typing to define the HLA A, B, and DR.
- One constant dose of ten bcr-abl peptides (100μg each) will be administered subcutaneously in all patients triweekly for 8 doses.
- Four different doses of IL-12 and GM-CSF plasmids will be tested in this trial. The plasmids will be administered subcutaneously near the vaccination site 24 hours before vaccination.
- The first three patients will receive the lower dose of both IL-12 and GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the lower dose of IL-12 plasmid and higher dose of GM-CSF plasmid. If this is well tolerated, then the next three patients will receive the higher dose of IL-12 and lower dose of GM-CSF plasmids. If this is well tolerated, then the next three patients will receive the higher dose of both IL-12 and GM-CSF plasmids. Once assigned to a dose, the patient will receive the same dose throughout their participation in this trial.
- Each vaccination may consist of one to several shots placed under the skin on the forearm, thigh or trunk area, and the sites will rotate per vaccination.
- During the clinic visit for vaccinations, blood tests will be drawn. If, during the course of therapy, side effects develop that the doctor feels pose a threat to the patient, treatment will be stopped.
- Patients will also undergo DTH skin tests before and after vaccination to see if an immune reaction is occurring at the injection site.
- Patients' lymphocytes will be tested before and after vaccination regarding IFN-γ and IL-4 production to assess immune system activation.
- During the course of treatment we will measure the effect the vaccine is having on the patients CML every three months by:
- doing a bone marrow biopsy and aspirate analysis, and
- measuring the amount of BCR-ABL that is detectable by RT-PCR in the patients' peripheral blood and bone marrow aspirate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Philadelphia chromosome positive CML who are:
- •of subtype b3a2
- •In first complete hematologic response;
- •have received imatinib for > 12 months of which the last 3 months were at a stable dose of at least 400 mg/day;
- •have PCR detectable BCR-ABL transcript by qRT-PCR, and
- •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
排除标准
- •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.
结局指标
主要结局
To assess safety of bcr-abl peptide vaccination in Ph+ or MRD CML patients
时间窗: At enroll in study and 3 months after intervention
次要结局
- 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(At enroll in study and 3 months after intervention)
研究者
研究点 (2)
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