Phase II Trial of Clofarabine and Cytarabine in Relapsed Standard-Risk AML and Untreated High-Risk MDS in Adult Patients, and Untreated AML in Selected Elderly Patients at High Risk of Anthracycline Toxicity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Response Rate (Complete Response [CR] Plus Partial Response [PR]) of Clofarabine Plus Cytarabine in Patients With Relapsed/Refractory AML, Untreated MDS, CML in Blast Phase, or in Selected Untreated Patients With High Risk of Anthracycline Toxicity
研究概览
简要总结
The purpose of this trial is to to determine the safety and effectiveness of therapeutic combination - Clofarabine and Cytarabine for the treatment of AML and MDS.
详细描述
Previous studies of Clofarabine and Cytarabine combination treatment in adult AML and MDS patients showed promising results.
This study is done to confirm the findings from previous studies. Primary objective is to determine the overall response rate (complete response [CR] plus partial response [PR]); secondary objective of this study is to characterize and quantify the toxicity profile associated with clofarabine plus cytarabine treatment.
A maximum of 35 patients will be treated on this study. They will receive 5 consecutive days of clofarabine intra venous infusion (IVI) followed 4 hours later by cytarabine IVI.Patients will receive up to a maximum of 4 cycles of study treatment. Next cycle will start approximately 4 weeks after Day 1 of previous cycle.No other investigational or commercial agents including chemotherapy, radiotherapy, or immunotherapy may be administered to patients enrolled in this study with the intention of treating the underlying malignancy
Patients will remain on study, and be monitored until 4 months have elapsed from the beginning date of their last cycle of treatment.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Laboratory values obtained less than or equal to 7 days prior to receiving study treatment:
- •Total bilirubin < 2.0 mg/dL unless elevated due to hemolysis
- •Aspartate transaminase (AST)/alanine transaminase (ALT) less than or equal to 5 × upper limit of normal (ULN)
- •Serum creatinine < 2.0 mg/dL
- •Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
- •Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
- •Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
排除标准
- •Patients with FAB M3 unless relapsed after treatment with ATRA and arsenic trioxide.
- •Patients eligible to receive curative allogeneic transplant as determined by performance status, organ function, availability of a matched donor, etc.
- •Current concomitant chemotherapy, radiation therapy, or immunotherapy.
- •Use of investigational agents within 30 days or any anticancer therapy within 3 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy.
- •Active heart disease including myocardial infarction within the preceding 3 months.
- •History of severe coronary artery disease, arrhythmias other than atrial flutter or fibrillation requiring medication, or uncontrolled congestive heart failure
- •Dyspnea at rest or with minimal exertion.
- •Patients with an active, uncontrolled systemic infection considered to be opportunistic, life-threatening, or clinically significant at the time of treatment or with a known or suspected fungal infection (ie, patients on parenteral antifungal therapy).
- •Pregnant or lactating patients.
- •Prior enrollment in this trial.
- •Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
研究组 & 干预措施
Clofarabine and Cytarabine
Five consecutive days of clofarabine 40 mg/m^2 IVI over 1 hour followed 4 hours later by cytarabine 1000 mg/m^2 IVI over 2 hours
干预措施: Clofarabine and Cytarabine (Drug)
结局指标
主要结局
Response Rate (Complete Response [CR] Plus Partial Response [PR]) of Clofarabine Plus Cytarabine in Patients With Relapsed/Refractory AML, Untreated MDS, CML in Blast Phase, or in Selected Untreated Patients With High Risk of Anthracycline Toxicity
时间窗: Proportion of confirmed responses was estimated by the number of patients who achieved a CR or PR, defined as two consecutive evaluations at least 4 weeks apart, divided by the number of eligible participants in the study.
Based on International working group for diagnosis, standardization of response criteria, and treatment outcomes for reporting standards for therapeutic trials in Acute myeloid Leukemia: Complete Response (CR) was defined as normalization of marrow blasts (\< 5%), recovery of normal heamtopoiesis (absolute neutrophil count \>1 X 10\^9/l, platelet count ≥100 X10\^9/l, and absence of peripheral blood blasts, independent of transfusions and growth factor support. Partial response was defined as blood count recovery as for complete response with the exception of leukemic marrow blasts in the range of 6%-25% or a ≥50% decrease in bone marrow blasts. Treatment failure was defined as a \<25% change in marrow blasts within 30 days of starting therapy
次要结局
- Number of Participants Who Had an Adverse Event While on Treatment With Clofarabine Plus Cytarabine(Up to five months (includes follow up period of 30 days) from the day patient received their first dose of study drug)