A Multi-Center Pilot Phase II Trial of a Synthetic Tumor-Specific Breakpoint Peptide Vaccine in Patients With Chronic Myeloid Leukemia (CML) and Minimal Residual Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Participants With One-log Decrease in Circulation Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) Transcripts That Persists for at Least Three Months During the 1-year Treatment Period.
研究概览
简要总结
RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill cancer cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with chronic phase chronic myelogenous leukemia.
详细描述
OBJECTIVES:
- Determine the antileukemic effects of tumor-specific Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) junction specific peptide vaccine, as measured by a decrease in circulating BCR-ABL transcripts by reverse-transcriptase polymerase chain reaction (RT-PCR), that persist for at least 3 months, in patients with chronic phase chronic myelogenous leukemia.
- Determine the percentage of patients treated with this vaccine who become RT-PCR-negative for BCR-ABL transcripts.
- Compare response in patients with B3A2 junctions vs B2A2 junctions when treated with this vaccine.
- Determine the immunologic response over 1 year in patients treated with this vaccine.
- Correlate response with specific HLA types in these patients.
- Determine the safety of this vaccine in these patients.
OUTLINE: This is a pilot, multicenter study.
Patients receive BCR-ABL junction-specific peptide vaccine subcutaneously in weeks 2, 4, 6, 8, and 11 and then once monthly for 10 months.
BCR-ABL transcript levels are assessed by quantitative reverse-transcriptase polymerase chain reaction at baseline, weeks 2, 4, and 6, every 3 months during treatment, and then 2 weeks after completion of study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of Philadelphia chromosome-positive or BCR-ABL-positive chronic phase chronic myelogenous leukemia (CML)
- •In complete cytogenetic remission confirmed by 2 bone marrows ≥ 1 month apart
- •Minimal residual disease
- •Detectable BCR-ABL transcript levels obtained < 6 months apart AND ≤ 0.5-log lower than the lowest value obtained within the past 6 months
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 80-100%
- •Bilirubin < 2 times upper limit of normal (ULN)
- •Creatinine < 1.5 times ULN
- •ALT and AST < 2.5 times ULN
- •PRIOR CONCURRENT THERAPY:
- •Recovered from prior therapy
- •No major surgery within the past 4 weeks
- •No prior chemotherapy
- •No prior immunosuppressive therapy
- •No prior corticosteroids
- •No prior stem cell transplantation
- •No radiotherapy within the past 4 weeks
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Number of Participants With One-log Decrease in Circulation Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) Transcripts That Persists for at Least Three Months During the 1-year Treatment Period.
时间窗: Every 3 months for the duration of the 1-year treatment period. .
One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.
Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts
时间窗: 12-24 Months
Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions
时间窗: 12-24 Months
Immunologic Response Over 1 Year
时间窗: 12 months
Correlation of Response With Specific HLA Types
时间窗: 12-24 Months
次要结局
- Safety of a Vaccine Containing Native and Synthetic Chronic Myeloid Leukemia (CML) Peptides Over 1 Year Treatment.(Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years.)