NCT03820908已完成2 期
Bisantrene for Relapsed /Refractory Acute Myelogenous Leukemia (AML)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Induction of response in patients with AML that are either primary resistant (failed induction and or salvage therapy) or relapsed including post allogeneic stem cell transplantation and failed salvage therapy or cannot receive additional anthracycline .
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
- •Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study.
- •Disease-related:
- •Patients with Rel/Ref/AML
- •Adequate birth control in fertile patients.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Demographic:
- •Age ≥ 18 years and willing and able to comply with the protocol requirements
- •Life expectancy ≥ 3 months Ethical/Other
- •Written informed consent in accordance with federal, local, and institutional guidelines.
- •Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception.
- •Male subjects must agree to practice contraception
排除标准
- •Disease-related
- •Patients with other type of basic disease other than Rel/Ref AML.
- •Patients with respiratory failure (DLCO < 30%).
- •Patients with active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention.
- •Patients with > grade II liver renal toxicity.
- •Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
- •Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
- •Creatinine > 2.0 mg/dl
- •ECOG-Performance status > 2
- •CNS disease involvement
- •Severe pleural effusion and ascites. Concurrent Conditions
- •Pregnant or lactating females
- •Known human immunodeficiency virus infection
- •Active hepatitis B or C infection
- •Non hematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
- •Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
- •Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
- •Patients with relapse or disease progression >3 months post HSCT are allowed into the study unless they have severe (grade III-IV) GVHD.
- •Patients with grade III-IV GVHD will be excluded from the study.
研究组 & 干预措施
Bisantrene
Experimental
patients will receive bisantrene 250mg/m2/d for 7 days
干预措施: Bisantrene (Drug)
结局指标
主要结局
Overall survival
时间窗: 24 months
Overall survival will be calculated from the day of bisantrene administration until death or last follow-up.
Leukemia-free survival
时间窗: 24 months
Leukemia-free survival will be calculated from the day of bisantrene administration until relapse, death of any cause, or last follow-up.
次要结局
未报告次要终点
研究者
Prof Arnon Nagler
Arnon Nagler, M.D., M.Sc Professor of Medicine Tel Aviv University, Director Hematology Division BMT and Cord Blood Bank, Chair Israeli BMT Association, Chair of the ALWP of the EBMT, Co-Chair Scientific Council of the EBMT
Sheba Medical Center
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Mitoxantrone for Venetoclax Resistant Acute Myeloid LeukemiaMyeloid LeukemiaLeukemiaMonocytic LeukemiaNCT06429449University of Colorado, Denver30
终止
1 期
Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic LeukemiaAcute Promyelocytic LeukemiaNCT00985530Northwestern University4
进行中（未招募）
1 期
Addition of venetoclax to standard chemotherapy with cytarabine and mitoxantrone in patients with relapsed or refractory acute myeloid leukemia (AML)EUCTR2018-003025-28-DETechnische Universität Dresden54
尚未招募
1 期
A Phase I, Open-Label, Dose Escalation and Cohort Expansion Study of BS HH 002.SA in Patients With AML and MDSAcute Myeloid Leukemia, Myelodysplastic SyndromeNCT04743115Shanghai Bensen Pharmaceutical Co., Ltd.66
终止
1 期
Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)Acute Myeloid LeukemiaNCT03552029Daiichi Sankyo10