Phase II Study of Fludarabine, Cytarabine (ARA-C) and Erwinase IV in Patients With Relapsed or Refractory Hematologic Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Overall Response of Fludarabine, Cytarabine, and Erwinase in Refractory/Relapsed Hematologic Malignancies
研究概览
简要总结
The goal of this clinical research study is to learn if fludarabine, cytarabine (ARA-C), and erwinase (also known as asparaginase [erwinia]) in combination can help to control relapsed or refractory hematologic malignancies. The safety of these drugs will also be studied.
详细描述
Study Drug Administration:
Each cycle is 28 days.
If participant is found to be eligible to take part in this study, they will receive treatment in 2 phases: Induction and Consolidation.
All participants will receive the same dose level of fludarabine, cytarabine, and erwinase. If the doctor thinks it is needed, the study drug doses may be reduced.
Induction Phase:
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of relapsed or refractory hematologic malignancy including, but not limited to Acute myeloid leukemia (AML), Acute lymphoblastic leukemia (ALL), Burkitt's leukemia/lymphoma, Prolymphocytic leukemia, Biphenotypic acute leukemia, Blast-phase of chronic myeloid leukemia (CML), B-cell lymphoma, or Richter's transformation of chronic lymphocytic leukemia (CLL)
- •Age </= 60 years.
- •Adequate organ function as defined below: liver function (bilirubin < 2mg/dL, AST and/or ALT <2.5 x upper limits of normal (ULN)), kidney function (creatinine < 1.5 x ULN ), known cardiac ejection fraction of > or = 45% within the past 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status of </=
- •A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
- •Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
- •Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
排除标准
- •Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.
- •Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patient with documented hypersensitivity to any of the components of the chemotherapy program.
- •Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
- •Patients with history of clinically significant venous thromboembolism.
研究组 & 干预措施
Fludarabine + Cytarabine + Erwinase
Induction Phase: Participants receive 1-2 cycles during the Induction phase.
Participants receive 1-2 cycles during the Induction phase.
Participants receive Fludarabine by vein on Days 1-5 and Cytarabine by vein.
Participants receive Erwinase by vein or as an injection into the muscle on Days 1-7.
Consolidation Phase: Participants receive up to 3 cycles during the Consolidation phase.
Participants receive Fludarabine by vein on Days 1-4 and Cytarabine by vein.
On Day 1 and then every other day for 15 days (3, 5, 7 and so on), participant receives Erwinase by vein or as an injection into the muscle.
干预措施: Fludarabine (Drug)
Fludarabine + Cytarabine + Erwinase
Induction Phase: Participants receive 1-2 cycles during the Induction phase.
Participants receive 1-2 cycles during the Induction phase.
Participants receive Fludarabine by vein on Days 1-5 and Cytarabine by vein.
Participants receive Erwinase by vein or as an injection into the muscle on Days 1-7.
Consolidation Phase: Participants receive up to 3 cycles during the Consolidation phase.
Participants receive Fludarabine by vein on Days 1-4 and Cytarabine by vein.
On Day 1 and then every other day for 15 days (3, 5, 7 and so on), participant receives Erwinase by vein or as an injection into the muscle.
干预措施: Cytarabine (Drug)
Fludarabine + Cytarabine + Erwinase
Induction Phase: Participants receive 1-2 cycles during the Induction phase.
Participants receive 1-2 cycles during the Induction phase.
Participants receive Fludarabine by vein on Days 1-5 and Cytarabine by vein.
Participants receive Erwinase by vein or as an injection into the muscle on Days 1-7.
Consolidation Phase: Participants receive up to 3 cycles during the Consolidation phase.
Participants receive Fludarabine by vein on Days 1-4 and Cytarabine by vein.
On Day 1 and then every other day for 15 days (3, 5, 7 and so on), participant receives Erwinase by vein or as an injection into the muscle.
干预措施: Erwinase (Drug)
结局指标
主要结局
Overall Response of Fludarabine, Cytarabine, and Erwinase in Refractory/Relapsed Hematologic Malignancies
时间窗: 56 days
Response assessed according to the Revised Recommendations of the International Working Group Response Criteria in Acute Myeloid Leukemia.
次要结局
- Disease-Free Survival (DFS) of Fludarabine, Cytarabine, and Erwinase in Refractory/Relapsed Hematologic Malignancies(21 days)