Phase 1 Study to Evaluate the Feasibility and Efficacy of the Addition of P1101 (PEG-Proline-Interferon Alpha-2b) to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response (MR 4.5 or BCR-ABL Transcripts Not Detectable)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Number and seriousness of adverse events to evaluate safety and tolerability
研究概览
简要总结
In this phase I pilot study, it is planned to investigate the feasibility and safety of adding an interferon therapy to an preexisting imatinib treatment in patients with chronic phase chronic myeloid leukaemia. The participating patients have already reached a response during their imatinib therapy (CCyR) but have still a detectable disease (no molecular response MR 4.5 or better).
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
- •Patients ≥ 18 years of age
- •BCR-ABL positive chronic myeloid leukaemia in chronic phase treated with imatinib as first line therapy
- •CHR, CCyR after at least 18 months of imatinib treatment
- •Adequate organ function, defined as the following:
- •total bilirubin < 1.5 x ULN,
- •AST and ALT < 2.5 x ULN,
- •creatinine < 1.5 x ULN,
- •ANC > 1.5 x 109/L,
- •platelets > 100 x 109/L
- •Written, voluntarily signed informed consent
排除标准
- •CMR (molecular remission 4.5 or BCR-ABL transcripts undetectable)
- •Patient has received any other investigational treatment within 28 days before study entry
- •Treatment with a second generation tyrosine kinase inhibitor (dasatinib, nilotinib)
- •ECOG performance status ≥ 3
- •Patients with a primary of a different histological origin than the study indication (unless relapse-free interval is ≥ 5 years, except cervical carcinoma, basal cell epithelioma or squamous cell carcinoma of the skin)
- •Evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease etc.)
- •Acute chronic infections
- •Known autoimmune disease (e.g. collagen disease, polyarthritis, immune thrombocytopenia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder)
- •Female patients who are pregnant or breast-feeding
- •Known diagnosis of HIV
研究组 & 干预措施
P1101
P1101 50µg s.c. will be administered every 2 weeks in addition to preexisting imatinib treatment. In the absence of dose limiting toxicities after 12 weeks, the dose will be escalated to 100µg every 2 weeks.
Maximum treatment duration will not expand 18 months.
干预措施: P1101 (Drug)
结局指标
主要结局
Number and seriousness of adverse events to evaluate safety and tolerability
时间窗: 30 months
The primary objective is to determine the safety and tolerability of the addition of P1101 to the pre-study established dose of imatinib.
次要结局
- Efficacy (Number of patients achieving an improvement of remission status)(30 months)