NL-OMON53052已完成3 期
A Randomized, Open-label, Controlled Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) - 20120215
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 8
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
- 12 至 17（—）
入选标准
- •* Subjects with Philadelphia (Ph-) chromosome negative high-risk (HR) first
- •relapse B-precursor ALL (as defined by I-BFM SG/IntReALL criteria), * Subjects
- •with M1 or M2 marrow at the time of randomization , * Age > 28 days and <18
- •years at the time of informed consent/assent, * 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
- •* Availability of the following material from relapse diagnosis for central
- •analysis of MRD by PCR: clone-specific primers and reference DNA, as well as
- •primer sequences and analyzed sequences of clonal rearrangements (cases with
- •isolated extramedullary relapse or cases with technical and/or logistic hurdles
- •to obtain and process bone marrow material are exempt from providing this
- •material. In these cases, central MRD analysis only by Flow is permitted).)
排除标准
- •* Clinically relevant CNS pathology requiring treatment (eg, unstable
- •epilepsy) Evidence of current CNS (CNS 2, CNS 3) involvement by ALL. Subjects
- •with CNS relapse at the time of relapse are eligible if CNS is successfully
- •treated prior to enrollment., * Abnormal renal or hepatic function prior to
- •start of treatment (day 1) as defined below:
- •a. Serum creatinine levels above upper limit of normal, based on the normal
- •ranges for age and gender of the local laboratories
- •b. Total bilirubin > 3.0 mg/dL prior to start of treatment (unless related to
- •Gilbert*s or Meulengracht disease)
- •* Peripheral neutrophils < 500/µl prior to start of treatment,
- •* Peripheral platelets < 50,000/µl prior to start of treatment,
- •* 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. Procedures required by IntReALL HR guidelines are
- •* Chemotherapy related toxicities that have not resolved to <= grade 2 ,
- •* 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,
- •* documented infection with HIV,
- •* Known hypersensitivity to immunoglobulins or any of the products or
- •components to be administered during dosing (excluding asparaginase),
- •* Post-menarchal subject who is pregnant or breastfeeding, or is planning to
- •become pregnant or breastfeed while receiving protocol-required therapy and for
- •at least 48 hours after the last dose of blinatumomab, or 12 months after the
- •last dose of chemotherapy
- •* Post-menarchal female subject who is not willing to practice true abstinence
- •or use a highly effective form of contraception while receiving
- •protocol-required therapy and for at least 48 hours after the last dose of
- •blinatumomab, or 12 months after the last dose of chemotherapy
- •* Sexually mature male subject who is not willing to practice true abstinence
- •or use a condom while receiving protocol-required therapy and for at least 48
- •hours thereafter ,
- •* Sexually mature male subject who is not willing to abstain from sperm
- •donation while receiving protocol-required therapy and for at least 48 hours
- •Refer to section 4.2 of the protocol.
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