EUCTR2014-001700-21-GB进行中（未招募）1 期
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17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
- 110
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. Immunophenotypic evidence of CD19 positive B-precursor ALL (pro
- •B-, pre B-, common ALL)
- •2. Age > 28 days and < 18 years at the time of informed consent/assent
- •3. Morphological or molecular evidence of relapsed/refractory disease,
- •defined as one of the following:
- •Second or later bone marrow relapse (defined as M3 marrow or M2
- •marrow or M1 marrow but with an MRD level = 10-3), or;
- •Any marrow relapse after alloHSCT (defined as M3 marrow or M2marrow or M1 marrow but with an MRD level = 10-3), 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 (Note: This does not include patients who
- •have already received blinatumomab treatment on this study, but refers
- •only to patients outside of the 20130320 study)
- •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) = 135 IU/L in the EU and Switzerland at least once during
- •ALT (SGPT) < 5 x upper limit of normal (ULN) for age in the United
- •States (US) at least once during screening
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •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 or hydroxyurea are allowed until start of blinatumomab).
- •7. Chemotherapy related toxicities that haven’t resolved to = grade 2
- •8. Radiotherapy within 4 weeks prior to blinatumomab treatment
- •9. Immunotherapy (eg, rituximab) within 6 weeks prior to blinatumomab treatment
- •10. 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.
- •11. Subject has known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing
- •12. 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
- •13. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive)
- •14. Subject is pregnant or breast feeding, or is planning to become pregnant within 24 hours after the last dose of blinatumomab
- •15. Adolescent female of childbearing potential and is not willing to use a highly effective form of contraception while receiving blinatumomab and for an additional 24 hours after the last dose of blinatumomab
- •16. Abnormal screening laboratory values as defined below:
- •Serum creatinine = 1.5 x ULN for age
- •Total bilirubin = 1.5 x ULN (unless related to Gilbert’s or Meulengracht disease)
- •17. Subject likely to not be available to complete all protocol-required study visits or procedures, including follow-up visits, and/or to comply with all required study procedures to the best of the subject’s and Investigator’s knowledge
- •18. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- •19. Active malignancy other than ALL
- •20. Subjects with Philadelphia chromosome negative (Ph-) high-risk (HR) first Relapse B-precursor ALL in continuous CR after treatment, but
- •with molecular failure or molecular relapse defined by MRD level o
研究者
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