EUCTR2012-002026-78-DE进行中（未招募）1 期
A Multicentre, open, randomized, controlled phase IIb trial evaluating efficacy and tolerability of GRASPA (L-asparaginase encapsulated in red blood cells,eryaspase) plus low-dose cytarabine vs low-dose cytarabine alone, in treatment of newly diagnosed acute myeloid leukemia (AML) elderly patients, unfit for intensive chemotherapy. - ENFORCE 1
ERYTECH Pharma0 个研究点目标入组 123 人开始时间: 2013年11月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 123
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients aged from 65 to 85 years old included
- •- Newly diagnosed Acute Myeloid Leukemia (AML) or post myelodysplastic syndrome diagnosed in the 6 months prior to study enrollment
- •- Unfit for intensive chemotherapy (at risk to suffer treatment related pejorative toxicities /early death) due to the presence of one or more of the following criteria:
- •o Dependence in activities of daily living owing to the presence of comorbidities other than those resulting from the deterioration caused by the neoplastic disease.
- •o Presence in the patient's medical history of three or more of the following comorbidities, even if they are under control with proper treatment:
- •- Congestive heart failure
- •- Other chronic cardiovascular diseases
- •- Chronic obstructive pulmonary disease
- •- Cerebrovascular disease
- •- Peripheral neuropathy
- •- Chronic kidney failure
- •- Hypertension
- •- Diabetes mellitus
- •- Systemic vasculitis
- •- Severe arthritis
- •o Presence of geriatric syndromes such as fecal or urinary incontinence, spontaneous bone fractures, mild and moderate dementia, or patients who fall repeatedly.
- •Patient unwilling to receive intensive chemotherapy
- •Eligible to receive low-dose cytarabine treatment
- •ECOG performance status = 2
- •Female patients of childbearing potential and males must agree to use
- •adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 6 months after the last dose of Cytarabine or 3 months after last dose of GRASPA (whichever is the longest).
- •Negative serum pregnancy test at study entry for female subjects of childbearing potential
- •Subscription to social security insurance (if applicable, in accordance with local regulations)
- •Ability to understand, and willingness to sign, a written informed consent document and to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 123
排除标准
- •- Patients with M3 AML of FAB classification (APL, acute promyelocytic leukemia)
- •- Patients with AML involving chromosome 16 abnormalities or translocation (8:21) (CBF-AML)
- •Patient with secondary AML subsequent to prior malignant blood disorder such as:
- •o Myelodysplastic syndrome diagnosed more than 6 months before study entry
- •o Myeloproliferative syndrome
- •Prior therapy to AML (standard therapy or investigational agents)
- •Inadequate organ function :
- •o Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis.
- •o Serum creatinine concentration > 2 x ULN (Upper Limit of Normal)
- •o AST or ALT levels > 3.5xULN or 5xULN if related to AML
- •o Total bilirubin > 2 x ULN
- •o INR > 1.5, unless patient under chronic treatment with anticoagulants (in this case, INR should be within expected ranges for the specific condition)
- •o Insulin-dependent or uncontrolled diabetes mellitus
- •Concurrent malignancies other than AML requiring chemotherapy
- •Severe active infection, HIV seropositivity, known active hepatitis B or
- •C infection
- •Known or suspected hypersensitivity or intolerance to mannitol
- •Contraindication to cytarabine treatment (according to country specific
- •approved Cytarabine SPC)
- •Breastfeeding or lactating women
研究者
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