NL-OMON35519已完成2 期
Bortezomib (Velcade®): A feasibility and phase II study in childhood relapsed acute lymphoblastic leukemia - Bortezomib in relapsed A
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •- Age between 6 months and 19 years
- •- patients with a second or subsequent relapsed ALL
- •- patients with first relapsed ALL after prior allogeneic stem cell transplantation in first complete remission
- •- patients with refractory first relapse of ALL, as defined by the ALL relapse protocol these patienst were enrolled in
- •- circulating leukemic blasts of at least 100/ul peripheral blood (i.e. at least 0.1x109/l)
- •- patients must take adequate contraceptives when of childbearing potential
- •- written informed consent
排除标准
- •- relapse not involving bone marrow
- •- symptomatic CNS leukemia
- •- Active uncontrolled infection
- •- Performance status (Lansky or Karnofsky score) of 60% or less
- •- Life expectancy of less than 6 weeks
- •- Existing peripheral neuropathy NCI grade 2 or higher
- •- Presence of acute diffuse infiltrative and/or pericardial disease
- •- Existing clinical signs of cardiotoxicity
- •- Previous allogeneic stem cell transplantation within 100 days
- •- Pregnant or breastfeeding
- •- Other contra-indications for chemotherapy, including no recovery from previous treatment
- •- Previous exposure to bortezomib
- •- other experimental or conventional antileukemic treatment within 7 days from start of bortezomib
- •- allergy to boron and its metabolites
- •- no concomitant anti-leukemic therapy other than according to this protocol
研究者
相似试验
进行中（未招募）
不适用
Bortezomib (Velcade®): a feasibility and phase II study in childhood relapsed acute lymphoblastic leukemia - Bortezomib in relapsed Aacute lymphoblastic leukemiaMedDRA version: 12.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentEUCTR2009-014037-25-NLErasmus MC24
进行中（未招募）
1 期
Bortezomib (Velcade®): a feasibility and phase II study in childhood relapsed acute lymphoblastic leukemia - Bortezomib in relapsed Aacute lymphoblastic leukemiaMedDRA version: 14.1Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-014037-25-DEErasmus MC24
进行中（未招募）
1 期
Bortezomib trial for the treatment of childhood relapsed acute lymphoblastic leukemiaacute lymphoblastic leukemiaMedDRA version: 14.1Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864EUCTR2009-014037-25-DKErasmus MC24
进行中（未招募）
1 期
Bortezomib (Velcade®): a feasibility and phase II study in childhood relapsed acute lymphoblastic leukemiaAcute lymphoblastic leukemia (ALL)MedDRA version: 14.1Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-014037-25-BEniversity Hospital Ghent29
进行中（未招募）
不适用
Bortezomib trial for the treatment of childhood relapsed acute lymphoblastic leukemiaEUCTR2009-014037-25-ATErasmus MC24