A Phase I-II Study of Oxaliplatin, Fludarabine, and Cytarabine in Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes at First Relapse With Complete Remission Duration < 1 Year
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Number of Participants With Objective Response
研究概览
简要总结
The goal of this clinical research study is to find the highest tolerable dose of oxaliplatin combined with fludarabine plus cytarabine that can be given to patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS). Once the highest tolerable dose of oxaliplatin in this drug combination is found, the next goal of the study will be to learn the safety and the ability of the drug combination to control the disease.
详细描述
The Study Drugs:
Cytarabine is designed to insert itself into Deoxyribonucleic acid (DNA) (the genetic material of cells) and stop the DNA from repairing itself.
Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.
Oxaliplatin is designed to "program" cells to cause death in leukemic cells.
The Phases of The Study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome.
- •Performance status 0-2 (Zubrod scale).
- •Serum creatinine equal or less than 1.3 mg/dL or creatinine clearance > 40 mL/min.
- •Bilirubin </= 2 mg/dL; serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) </= 3 times the Upper Limit of Normal (ULN) for the reference lab unless due to leukemia or congenital hemolytic disorder (for bilirubin).
- •Written informed consent.
排除标准
- •No untreated or uncontrolled life-threatening infection.
- •No oxaliplatin, fludarabine, or cytarabine intolerance.
- •No pregnancy or lactation. Female patients of childbearing potential (including those < 1 year post-menopausal) and male patients must agree to use contraception.
- •No chemotherapy or radiation therapy within 4 weeks of study entry. Hydroxyurea is allowed prior to starting therapy in the setting of rapidly proliferating disease.
- •No other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or to interfere with the interpretation of the results.
研究组 & 干预措施
Oxaliplatin + Cytarabine + Fludarabine
Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
干预措施: Oxaliplatin (Drug)
Oxaliplatin + Cytarabine + Fludarabine
Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
干预措施: Fludarabine (Drug)
Oxaliplatin + Cytarabine + Fludarabine
Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
干预措施: Cytarabine (Drug)
结局指标
主要结局
Number of Participants With Objective Response
时间窗: After 2 months
Objective response: Complete Response/Remission (CR) defined as a bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10\^9/Liters or more and platelet count of 100\*10\^9/Liters or more; Complete Response with Platelets/remission without platelet recovery (CRp) defined as a complete response except for a platelet less than 100\*10\^9/Liters and transfusion independent; and Partial Response/Remission defined as peripheral blood count recovery as for CR with decrease in marrow blasts \>/= 50% and not more than 6-25% abnormal cells in the marrow.
次要结局
未报告次要终点