EUCTR2014-002476-92-DE进行中（未招募）1 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)
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
- Amgen Inc
- 入组人数
- 202
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
- •* 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 (< 25% leukemic cells by
- •cytomorphology) 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).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 202
- •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
- •* 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.
- •* 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). Procedures required by
- •IntReALL HR guidelines are allowed.
- •* 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.
- •* 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.
- •* 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.
- •* Placed into an institution due to juridical or regulatory ruling.
- •* Abnormal renal or hepatic function prior to start of treatment (day 1)
- •as defined below:
- •a. Abnormal serum creatinine based on age/gender
- •b. Total bilirubin = 3.0 mg/dL prior to start of treatment (unless related
- •to Gilbert's or Meulengracht disease)
- •* Chemotherapy related toxicities that have not resolved to = grade 2
- •* Documented infection with HIV
- •* Known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing (excluding asparaginase)
- •* Post-menarchal female subject who is pregnant or breastfeeding, or is planning to become pregnant or breastfeed while receiving protocolspecified therapy and for at least 12 months after the last dose of chemotherapy.
- •* Post-menarchal female subject who is not willing to practice true sexual abstinence or use a highly effective form of contraception while receiving protocol-specified therapy and for at least 12 months after the last dose of chemotherapy.
- •* Sexually mature male subject who is not willing to practice true sexual abstinence or use a condom with spermicide while receiving protocolspecified therapy and for at least 6 months after last dose of chemotherapy. In countries where spermicide is not available, a condom without spermicide is acceptable.
- •* Sexually mature male subject who is not willing to abstain from sperm
- •donation while receiving protocol-specified therapy and for at least 6 months after last dose of chemotherapy
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