A Phase II, Open-Label, Single- Center Study to Assess the Activity of Oshadi D and Oshadi R in Combination With Salvage Chemotherapy for Relapsed or Refractory Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) Patients
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 15
- 主要终点
- Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation.
研究概览
简要总结
The study will be a prospective open-label single-center study in previously treated patients with Acute Myeloid Leukemia (AML) or Acute Lymphoid Leukemia (ALL). Treatment efficacy and safety of the combination of Oshadi D (DNase in Oshadi carrier) and Oshadi R (RNase in Oshadi carrier) with Salvage Chemotherapy will be evaluated. Oshadi D and Oshadi R were shown to have anti-tumor activity and good safety profile.
Patients will receive Oshadi D and Oshadi R oral treatment combined with salvage chemotherapy. Patient will be evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D and Oshadi R.
Efficacy will be determined by percentage of bone marrow blasts assessment at day 28 post therapy initiation.
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 is diagnosed as AML or ALL
- •Relapse defined as the presence of disease after the achievement of complete remission(CR). Refractory disease is defined as progression from or no response while treated with a previous line chemotherapy regimen, or progression within 30 days of last bone marrow assessment.
- •Male or female ≥ 18 years of age
- •Minimal performance status (ECOG 0, ≤2)
- •Patients must have a measurable disease by bone marrow blast counts of > 5 % of nucleated cells.
- •Written informed consent
- •Adequate hepatic function (LFTs up to X4 the normal limits), renal function calculated Creatinine clearance (CrCl) for Adverse Effects of >30)
- •Ability to swallow the medications.
- •Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
排除标准
- •Active infectious disease uncontrolled by antibiotics.
- •Partially treated induction patients (i.e. day 14 non responding patients).
- •Inability to receive high dose salvage chemotherapy.
- •Patient with known positive HIV serology at screening.
- •Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
- •Evidence of ongoing cardiac dysrhythmias of NCI Common Toxicity Criteria for Adverse Effects (CTCAE ) Version 3.0 grade
- •Pre-existing mal absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
- •Mental disorders.
- •Inability to give written informed consent.
研究组 & 干预措施
'Oshadi D & Oshadi R; salvage therapy'
Oshadi D (180mg/tid) & Oshadi R (180mg/tid) will be administrated orally; Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days) will be administrated
干预措施: Oshadi D & Oshadi R; (Drug)
'Oshadi D & Oshadi R; salvage therapy'
Oshadi D (180mg/tid) & Oshadi R (180mg/tid) will be administrated orally; Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days) will be administrated
干预措施: salvage therapy cytosar and mitoxantrone (Drug)
结局指标
主要结局
Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation.
时间窗: 28 days
Percentage of bone marrow blasts aspirate before treatment initiation and at day 28 following treatment initiation.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(28 days)