NCT02197650No Longer Available不适用
Expanded Access Program for a Multicentre, Open, Non Randomized Study, Evaluating Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase
ERYtech Pharma10 个研究点 分布在 1 个国家开始时间: 2014年7月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 10
研究概览
简要总结
Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.
详细描述
Some patients can not be eligible to other clinical trials / program sponsored by Erytech Pharma but could have a benefit to be treated with GRASPA. Following discussion with French regulatory authorities, it has been suggested to propose access to GRASPA to patients unable to receive any other form of L-asparaginase and not eligible to the ongoing study or other program. This exploratory study should allow it in an "Expended Access Program" framework.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- — 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ALL de novo or in relapse or refractory
- •Eligible to a chemotherapy treatment including L-asparaginase
- •Known contraindication and/or at risk of toxicity to other L-asparaginase formulation according to investigator opinion based on information available
- •Patient under 55 years old
- •Patient informed and consent provided (the 2 parents need to consent for children).
排除标准
- •Patient unable to receive GRASPA due to general or visceral conditions
- •Serum creatinine ≥ 2 x ULN unless related to ALL
- •ALT or AST ≥ 3 x ULN unless related to ALL
- •Active clinical pancreatitis any grade or pancreatic enzyme elevation ≥ 1.5 ULN
- •Other serious conditions according to investigator's opinion.
- •Absence of documented serological test for HIV, B and C hepatitis
- •History of grade 3 transfusional incident or any contraindication to receive blood transfusion
- •Patient under concomitant treatment likely to cause hemolysis
- •Presence of specific anti-erythrocyte antibodies preventing from getting a compatible erythrocyte concentrate for the patient.
- •Patient undergoing yellow fever vaccination.
- •Patient under phenytoin treatment.
- •Women of childbearing potential without effective contraception as well as pregnant or breast feeding women.
- •Patient already included in another clinical trial
研究者
研究点 (10)
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