A Phase II Study of Isavuconazole Prophylaxis in Adult Patients With AML/MDS and Neutropenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of Participants With Proven or Probable Invasive Fungal Infections (IFIs)
研究概览
简要总结
This phase II trial studies how well isavuconazole works in preventing invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome and neutropenia. Isavuconazole may help to prevent invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome and neutropenia.
详细描述
PRIMARY OBJECTIVES:
I. To assess whether prophylaxis with isavuconazole effectively prevents the occurrence of proven or probable invasive fungal infections (IFIs) in patients with newly diagnosed acute myeloid leukemia/myelodysplastic syndrome (AML/MDS) receiving successive cycles of intensive chemotherapy or other therapies for up to 100 days from prophylaxis initiation.
SECONDARY OBJECTIVES:
I. To evaluate the incidence of invasive aspergillosis (IA) within 100 days of beginning isavuconazole prophylaxis in newly diagnosed patients with AML/MDS receiving intensive chemotherapy or other therapies.
II. To evaluate the incidence of other IFIs within 100 days of beginning isavuconazole prophylaxis in newly diagnosed patients with AML/MDS receiving intensive chemotherapy or other therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients with either newly diagnosed AML or MDS who have either begun (within 4 days of starting study drug) or are planned to begin specific treatment for their AML/MDS; hydroxyurea and cytarabine used for cytoreduction while awaiting initiation of definitive therapy are not considered "specific" treatment; patients who are participating in other therapeutic clinical trials for their AML/MDS may participate in this trial
- •Patients must have or be anticipated to have neutropenia (absolute neutrophil count [ANC] < 0.5 x 10^9/L) (75) for >= 7 days as a result of treatment of their AML/MDS
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- •Total bilirubin =< 3 x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5 x ULN
- •Patients must be able to take oral medications, although a brief period of IV therapy (< 4 days) is permitted at trial entry
- •Patients must be willing and able to provide written informed consent for the trial
- •Women of childbearing potential (WOCBP) must practice 2 effective methods of birth control during the course of the study; male patients who are partners of WOCBP should also practice an effective method of contraception; effective methods of birth control include diaphragm or condoms with spermicidal foam or jelly, birth control pills (BCPs), injections or patches, intra-uterine devices (IUDs) and surgical sterilization
- •Postmenopausal women must be amenorrheic for >= 12 months to be considered of non-childbearing potential
- •Women and men must continue birth control for the duration of the trial and >= 3 months after the last dose of study drug
- •All WOCBP MUST have a negative pregnancy test prior to first receiving study medication
排除标准
- •Proven, probable or possible IFI within the previous 30 days
- •Use of any systemic antifungal therapy for > 72 hours during the week prior to study drug initiation
- •History of hypersensitivity or idiosyncratic reactions to azoles
- •Patients with familial short QT syndrome or with corrected QT (QTc) interval =< 300 ms
- •Patients on strong CYP3A4 inducers or inhibitors that cannot be discontinued
- •Women who are pregnant or nursing, or intend to be/do so during the course of the study
- •Patients with severe hepatic impairment (Child-Pugh class C)
- •Patients with known or suspected Gilbert's syndrome at the time of study enrollment
- •Patients with known gastrointestinal conditions that could potentially interfere with absorption of orally administered medications
- •Any condition that, in the opinion of the investigator, may interfere with the objectives of the study, e.g., any condition requiring the use of prohibited drugs or unstable medical conditions other than AML/MDS, such as a cardiac or neurologic disorder expected to be unstable or progressive during the course of the study (e.g., seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia or unstable congestive heart failure, unstable arrhythmias)
研究组 & 干预措施
Prevention (isavuconazole)
Patients receive isavuconazole PO every 8 hours for 6 doses and then Once a day (QD) or IV over 1 hour every 8 hours for 6 doses and then QD for up to 4 days for 12 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: Isavuconazole (Drug)
结局指标
主要结局
Number of Participants With Proven or Probable Invasive Fungal Infections (IFIs)
时间窗: Up to 100 days from prophylaxis initiation
Participants with proven or possible invasive fungal infections.
次要结局
- Invasive Fungal Infections (IFIs)-Free Survival(Up to 3 years)
- Time to Death From Any Cause(Up to 3 years)
- Number of Participants With Death Related to Invasive Fungal Infections (IFIs)(Up to 3 years)
- Time to Diagnosis of Proven or Probable Invasive Fungal Infections (IFIs)(Up to 3 years)
- Time to Initiation of Empiric Anti-fungal Therapy(Up to 3 years)
- Number of Participants With Invasive Aspergillosis(Up to 100 days from prophylaxis initiation)
- Number of Participants With Treatment Success(Up to 3 years)
- Number of Participants Who Failed Treatment(Up to 3 years)
- Overall Survival (OS)(Up to 3 years)
- Number of Participants With Other Invasive Fungal Infections (IFIs)(Up to 100 days from prophylaxis initiation)