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2018年2月1日

概览

暂无简介。

注册库

who.int

开始日期

2018年2月1日

结束日期

待定

最后更新

去年

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Princess Máxima Center for Pediatric Oncology

•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

•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: