A Phase 2 Study of E7070, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Overall Response
研究概览
简要总结
The goal of this clinical research study is to learn if E7070 in combination with idarubicin, cytarabine, and dexamethasone can help to control the disease in patients with either AML or high-risk MDS that has relapsed. The safety of the drug combination will also be studied.
详细描述
The Study Drugs:
E7070 is designed to stop metabolic ingredients from reaching the cancer cells and to stop the cancer cell from dividing.
Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.
Idarubicin is designed to cause breaks in both strands of DNA (the genetic material of cells).
Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to AML patients in combination with other chemotherapy to treat cancer.
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
- •All patients with histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (AML) [except acute promyelocytic leukemia], or high-risk myelodysplastic syndrome (HRMDS) (Int-2 high risk by International Prostate Symptom Score (IPSS) or >10% blasts in marrow).
- •Patients must be 18 years or older.
- •Patients must have a performance status of 0-2 (Zubrod scale).
- •Patients must have adequate renal function (serum creatinine less than or equal to 1.3 mg/dL and/or creatinine clearance > 40 mL/min). Patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the Principal Investigator (PI) (up to creatinine less than or equal to 2.0), and appropriate dose adjustments will be considered.
- •Patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; SGOT or Serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 times the ULN for the reference lab unless due to leukemia or congenital hemolytic disorder or bilirubin). Patients with hepatic dysfunction (SGOT/SGPT up to less than or equal to 5 X ULN) due to organ infiltration by disease may be eligible after discussion with the PI, and appropriate dose adjustments will be considered.
- •Patients must have normal cardiac ejection fraction
- •QTc interval </= 480 msecs.
- •Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
- •Female patients must not be pregnant or lactating. Female patients of childbearing potential (including those <1 year post-menopausal) and male patients must agree to use contraception.
排除标准
- •Patients must not have untreated or uncontrolled life-threatening infection.
- •Patients must not have received chemotherapy and/or radiation therapy within 2 weeks. Hydroxyurea is allowed up to 48 hours prior to starting therapy in the setting of rapidly proliferating disease. Use of hydroxyurea to control proliferative disease will be allowed starting from day 2 until day 7 Cycle
- •Maximum dose of hydroxyurea allowed daily is 5 gram and hydroxyurea must be discontinued once administration of idarubicin and cytarabine is started.
- •Any other medical condition, including mental illness or substance abuse, deemed by the PI to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or with the interpretation of the results.
- •Patients must not have received an investigational anti-cancer drug within two weeks of E7070 administration.
研究组 & 干预措施
E7070 + Idarubicin + Cytarabine
E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age > 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.
干预措施: E7070 (Drug)
E7070 + Idarubicin + Cytarabine
E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age > 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.
干预措施: Idarubicin (Drug)
E7070 + Idarubicin + Cytarabine
E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age > 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.
干预措施: Cytarabine (Drug)
E7070 + Idarubicin + Cytarabine
E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age > 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Overall Response
时间窗: 2 cycles (60 days)
Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.
次要结局
- Overall Survival(Up to 5 years)
- Disease-free Survival(Up to 5 years)
- Duration of Response(Up to 5 years)