Open Label, Non-randomized, Phase II Study on Fractioned Cyclophosphamide, Vincristine, Liposomal Doxorubicin or Doxorubicin, and Dexamethasone (MY HYPER-CVAD) in the Treatment of Relapsed Refractory Adult Acute Lymphoid Leukemia
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Type, frequency, severity, timing and relatedness of adverse events (AE)
研究概览
简要总结
The patient receive 2 different drug combinations on this study. The first combination will consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate, doxorubicin liposomal or doxorubicin, vincristine, ARA-C (cytarabine) and dexamethasone). The second combination will consist of another intensive chemotherapy regimen (methotrexate and Ara-C [cytarabine]).
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
- •Diagnosis of ALL (any type included), in patients who:
- •have relapsed after conventional chemotherapy* or,
- •are refractory to at least 1 cycle of chemotherapy*
- •ECOG Performance score of 0-3
- •Adequate hepatic and renal function, as defined by serum transaminases <2.5x ULN, bilirubin <1.5xULN, and creatinine <1.5x ULN.
- •Age 18 years or greater.
- •Documentation of written informed consent to participate in the trial.
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •at least 3 weeks from prior chemotherapy or other investigational anticancer therapy with full recovery from prior toxicities.
- •either men or women, accepting to practice effective contraception during the entire study period unless documentation of infertility exists.
排除标准
- •Treatment with any investigational agent within 3 weeks prior to study therapy.
- •Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure.
- •Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to:
- •Presence of central nervous system (CNS) leukemia.
- •Active uncontrolled bacterial infection.
- •Known human immunodeficiency virus (HIV) infection.
- •Significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina), or a major thromboembolic event (myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last 6 months.
- •Pregnancy or breast-feeding.
- •Malabsorption syndromes
研究组 & 干预措施
1
The patient receive 2 different drug combinations on this study. The first combination will consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate, doxorubicin liposomal or doxorubicin, vincristine, ARA-C (cytarabine) and dexamethasone). The second combination will consist of another intensive chemotherapy regimen (methotrexate and Ara-C [cytarabine]).
干预措施: doxorubicin liposomal (Drug)
结局指标
主要结局
Type, frequency, severity, timing and relatedness of adverse events (AE)
时间窗: weekly
CR rate after any treatment cycle and at the end of the study
时间窗: monthly
次要结局
- The percentage of hematological responders after any treatment cycle(monthly)
- The percentage of cytogenetic and molecular responders after any treatment cycle in patients for whom genetic markers of minimal residual disease are available(monthly)
- Relapse free survival at month 6 and 12(every 6 months)
- Overall survival at month 6 and 12(every 6 months)
- The percentage of patients submitted to SCT after CR re-induction(every 6 months)