NCT04914676终止2 期
Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) in Complete Remission
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Duration of Neutropenia
研究概览
简要总结
This phase 2, open label, non-randomized study will evaluate the safety of administering high dose cytarabine (HiDAC) consolidation therapy on days 1-3 of each cycle, as compared to standard administration on days 1, 3, and 5 of each cycle, in patients 61 years and older with de novo acute myeloid leukemia (AML).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 61 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both males and females ≥ 61 years of age
- •A clinical diagnosis of de novo, non-M3 acute myeloid leukemia (AML) confirmed by greater than 20% blasts in peripheral blood or on diagnostic bone marrow biopsy who have completed intensive induction chemotherapy and are confirmed in complete remission #1 (defined by < 5% myeloblasts on recovery bone marrow biopsy, Absolute neutrophil count > 1000/uL and platelets > 100x103/uL) and able to receive HiDAC consolidation #1
- •Patients on the prospective arm must be willing to have labs/clinic visits at UF Health Shands approximately every 48 hours +/- 24 hours after discharge from chemotherapy admission to be included. If prospective subjects cannot be followed at the UF site then telephone visits are allowed to follow for toxicity and transfusions. Records can be requested from subject's local physician office.
- •Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures. For subjects on the historical arm, there will be a waiver of informed consent (as these patients may be deceased or not be available for retrospective consent).
排除标准
- •Age < 61 years
- •Patients unable to provide informed consent for prospective arm
- •Secondary AML (documented history of antecedent hematological disorder, such as myelodysplastic syndrome or therapy-related AML) or chronic myeloid leukemia (CML) in blast crisis
- •Patients receiving, received, or who will receive a FLT3 inhibitor
- •Patients receiving, received, or who will receive an IDH1 or IDH2 inhibitor
- •Serum creatinine greater than 2 mg/dL
- •History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician
- •Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
- •For historical arm, subjects will be excluded if adequate data is not available in electronic medical record (e.g., if patient was followed by their local oncologist between chemotherapy cycles and labs/transfusions/clinic notes, etc. are not available)
- •Karnofsky performance status of 40 or less at study entry
研究组 & 干预措施
Prospective HiDAC Treatment (HiDAC 123)
Experimental
Subject on this arm will be treated with HiDAC prospectively.
干预措施: Cytarabine (Drug)
Historical HiDAC Treatment (HiDAC 135)
Other
Subjects on this arm will be historical controls who have previously received treatment with HiDAC.
干预措施: Cytarabine (Drug)
结局指标
主要结局
Duration of Neutropenia
时间窗: 5 months
Determine the duration of neutropenia in older patients with de novo AML after consolidation chemotherapy with HiDAC 123, as compared to historical controls treated with HiDAC 135.
次要结局
- Readmission Rates and Length of Readmission Stay(5 months)
- Time to Next Treatment(5 months)
- Duration of Thrombocytopenia(5 months)
- Incidence of Documented Infections(5 months)
- Number of Transfusions(4 months)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
AAV Gene Therapy Study for Subjects with PKUPhenylketonuria (PKU)NCT04480567BioMarin Pharmaceutical100
已完成
2 期
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With Basal Cell CarcinomaBasal Cell CarcinomaNCT04669808Sirnaomics32
已完成
1 期
RBM-007 in Subjects witH ExudatIve Age-related Macular DegenerationAge-related Macular DegenerationNCT03633084Ribomic USA Inc9
终止
1 期
Gene Therapy Clinical Study in Adult PKUPhenylketonuriasPAH DeficiencyNCT03952156Homology Medicines, Inc10
终止
1 期
Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)NeoplasmsNCT00954512Merck Sharp & Dohme LLC15