EUCTR2016-004674-17-AT进行中（未招募）1 期
A pilot study to test the feasibility, safety and efficacy of the addition of the BiTE antibody Blinatumomab to the Interfant-06 backbone in infants with MLL-rearranged acute lymphoblastic leukemia. A collaborative study of the Interfant network.
Princess Máxima Center for Pediatric Oncology0 个研究点目标入组 30 人开始时间: 2018年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •1.Patients must be treated according to Interfant-06 backbone
- •2.Patients must have newly diagnosed, CD19 positive, B-precursor acute lymphoblastic leukemia
- •3.Morphological verification of the diagnosis, confirmed with immunophenotyping
- •4.= 365 days of age at time of diagnosis of ALL
- •5.> 28 days of age at start of blinatumomab administration
- •6.MR and HR patients according to risk stratification of the Interfant-06 protocol (see table 1), thus including all MLL-rearranged and MLL not-evaluable patients (these latter are stratified and treated according to MR).
- •7.M1 or M2 bone marrow after induction (~day 33).
- •If the peripheral blood shows pancytopenia at day 33 it is justified to postpone the bone marrow puncture according to the Interfant-06 protocol. If the bone marrow at day 33 is hypocellular and one is therefore unable to determine M1 or M2 status, then the bone marrow puncture should be repeated.
- •8.Written informed consent from parents or guardians
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Biphenotypic ALL
- •2.Mature B-ALL
- •3.Presence of t(9;22) (q34;q11) or BCR-ABL fusion transcript
- •4.M3 marrow after induction
- •5.Patients with Down syndrome (because of increased toxicity of conventional chemotherapy)
- •6.Clinically relevant CNS pathology requiring treatment (eg unstable epilepsy)
- •7.Evidence of CNS involvement of ALL (CNS2 or CNS3) at the end of induction. Subjects with CNS disease at the time of diagnosis are eligible if a CNS1 status is obtained prior to enrolment (lumbar puncture at ~day 29 of induction, see definitions CNS status in Appendix D)
- •8.Known infection with human immunodeficiency virus (HIV)
- •9.Known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing
- •Exclusion criteria before start (-d3) of blinatumomab:
- •1.Peripheral neutrophils <0.5 x 109/l and WBC <2 109/l (for M1 marrow only, with a maximum delay of 2 weeks. Patients with M2 bone marrow will not recover their blood counts and can start as soon as the other inclusion criteria are met)
- •2.Peripheral platelets < 50 x 109/L (for M1 marrow only with a maximum delay of 2 weeks. Patients with M2 bone marrow will not recover their blood counts and can start as soon as the other inclusion criteria are met)
- •3.Creatinine > 1.5 X ULN, based on the normal ranges for age and gender of the local laboratories
- •4.Total bilirubin > 3 x ULN unless the patient has documented Gilbert Syndrome
- •5.Chemotherapy related toxicities that have not resolved to = grade 2
- •6.Symptoms and/or clinical signs and/or radiological and/or sonographic signs that indicate an acute or uncontrolled chronic infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol
研究者
相似试验
进行中（未招募）
1 期
Blinatumomab in infant AAcute Lymphoblastic LeukemiaEUCTR2016-004674-17-DEPrincess Máxima Center for Pediatric Oncology30
进行中（未招募）
1 期
Blinatumomab in infant acute lymphoblastic leukemia (ALL)Cancer - Children's - Leukaemia & LymphomaAcute Lymphoblastic LeukemiaACTRN12620000542998Princess Máxima Center for Pediatric Oncology30
进行中（未招募）
1 期
Blinatumomab in infant AAcute Lymphoblastic LeukemiaEUCTR2016-004674-17-NLPrincess Máxima Center for Pediatric Oncology30
进行中（未招募）
1 期
Blinatumomab in infant AAcute Lymphoblastic LeukemiaMedDRA version: 21.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864EUCTR2016-004674-17-CZPrincess Máxima Center for Pediatric Oncology30
已完成
不适用
Blinatumomab in infant A<p>acute lymphoblastic leukemia (ALL) Acute lymfatische leukemie (ALL)</p>NL-OMON24025Princess Maxima Center for Pediatric Oncology30