A Phase I/II Clinical Trial of Omacetaxine, Azacitidine, and G-CSF for Relapsed and/or Refractory Myelodysplastic Syndromes
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The maximum tolerated dose (MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed and/or refractory low- and intermediate-risk MDS.
研究概览
简要总结
The purpose of this study is to determine the safety and establish the maximum tolerated dose (MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed and/or refractory MDS.
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
- •Age >= 18 years;
- •Informed consent;
- •Low- and intermediate-risk MDS that has failed to achieve any hematologic improvement after at least 4 cycles of induction therapy or has relapsed after any duration of any hematologic response. Prior therapy with azanucleosides (i.e., azacitidine, decitabine), biologic therapies (i.e., lenalidomide, rigosertib) and hematopoietic cell transplant are permissible;
- •Performance status must be Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2;
- •Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) may participate, provided they meet the following conditions:
- •Must agree to use physician-approved contraceptive methods throughout the study and for three months following the last dose of omacetaxine and
- •Must have a negative serum or urine pregnancy test within 7 days prior to beginning treatment on this trial;
- •Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving a child for 6 months following the last dose of omacetaxine.
排除标准
- •Subjects who are eligible for hematopoietic stem cell transplant;
- •History of atrial fibrillation related to azanucleoside therapy in the past;
- •Active, uncontrolled, clinically significant infection;
- •Pregnant and nursing patients are excluded because the effects of omacetaxine on a fetus or nursing child are unknown;
- •Treatment with any anticancer therapy (standard or investigational) within the previous 14 days prior to the first dose of study drug or less than full recovery from the clinically significant toxic effects of that treatment.
研究组 & 干预措施
Arm 1
Omacetaxine - escalating doses subcutaneous twice daily on Days 1-5 and 8-12 Azacitidine 50 mg/m2 subcutaneous/intravenous daily on Days 8-12 G-CSF 5mcg/kg subcutaneous daily on Days 15-19 and 22-26
干预措施: Omacetaxine (Drug)
Arm 1
Omacetaxine - escalating doses subcutaneous twice daily on Days 1-5 and 8-12 Azacitidine 50 mg/m2 subcutaneous/intravenous daily on Days 8-12 G-CSF 5mcg/kg subcutaneous daily on Days 15-19 and 22-26
干预措施: Azacitidine (Drug)
Arm 1
Omacetaxine - escalating doses subcutaneous twice daily on Days 1-5 and 8-12 Azacitidine 50 mg/m2 subcutaneous/intravenous daily on Days 8-12 G-CSF 5mcg/kg subcutaneous daily on Days 15-19 and 22-26
干预措施: G-CSF (Drug)
结局指标
主要结局
The maximum tolerated dose (MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed and/or refractory low- and intermediate-risk MDS.
时间窗: 28 days
次要结局
- Number of participants with disease response as defined by International Working Group (IWG) 2006 criteria.(12 months)
- Number of participants who achieve complete remission and how long the response lasts(24 months)
- Number of participants with Hematologic Improvement (HI) as measured by hemoglobin, platelet count and neutrophil count.(12 months)
- Length of time of survival for participants(24 months)
- Incidences of Grade 3/4 adverse events directly related to the drug combination(24 months)