An Open-Label, Multi-center, Expanded Access Protocol of Blinatumomab for the Treatment of Pediatric and Adolescent Subjects with Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (Rialto Study) - Rialto Study

Amgen Inc.0 个研究点目标入组 110 人开始时间: 2014年9月25日最近更新: 2020年11月30日

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: 110

研究概览入排标准研究者记录与标识符相似试验

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. Morphologic and immunophenotypic evidence of CD19 positive B-precursor ALL (pro B-, pre B-, common ALL) with = 5% blasts in bone marrow (M2 and M3) at study enrollment
•2. Age > 28 days and < 18 years at the time of informed consent/assent
•3. Relapsed/refractory disease, defined as one of the following:
•Second or later bone marrow relapse;
•Any marrow relapse after alloHSCT; or
•Refractory to other treatments:
•o For patients in first relapse: failure to achieve a CR following a full standard reinduction chemotherapy regimen
•o For patients who have not achieved a first remission: failure to achieve remission following a full standard induction regimen
•Subjects previously treated with blinatumomab may be eligible, if subject ended treatment for reason(s) other than disease progression or intolerability to blinatumomab
•4. Subject’s legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/ procedures being initiated
•5. Subject does not qualify for, or cannot access other comparable or satisfactory alternative therapy for CD19 positive B-precursor ALL
•6. Adequate liver function defined as:
•ALT (SGPT) < 5 x upper limit of normal (ULN) for age at least once during screening
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•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. Any active acute Graft-versus-Host Disease (GvHD) grade 2 to grade 4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment
•2. Immunosuppressive agents to prevent or treat GvHD within 2 weeks prior to blinatumomab treatment (except for topical corticosteroids)
•3. Active (overt) ALL in the CNS (confirmed by cerebrospinal fluid [CSF] analysis) or in testes
•4. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis
•- With the exception of CNS leukemia that is well controlled with intrathecal therapy
•5. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
•6. Cancer chemotherapy within 2 weeks prior to start of blinatumomab (except for tyrosine kinase inhibitors (TKI) and/or low dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, glucocorticoids; intrathecal chemotherapy and dexamethasone are allowed until start of blinatumomab).
•7. Radiotherapy within 2 weeks prior to blinatumomab treatment
•8. Immunotherapy (eg, rituximab) within 4 weeks prior to blinatumomab treatment
•9. Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(s). Other investigational procedures while participating in this study are excluded.
•10. Subject has known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing

研究者

发起方

Amgen Inc.

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