NCT06054113进行中（未招募）2 期
An Open-label, Multicenter, Phase 2 Study to Evaluate Efficacy, Safety, and Pharmacokinetics (PK) of Blinatumomab in Chinese Pediatric Subjects With Relapsed or Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 18
- 试验地点
- 7
- 主要终点
- Number of Participants with CR with Partial Recovery of Peripheral Blood Counts (CRh)
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of blinatumomab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 204 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant's parent or legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated
- •Pediatric participants aged > 1 month and < 18 years at the time of informed consent
- •Relapsed or/refractory precursor B-cell acute lymphoblastic leukemia (ALL) disease, defined as ≥5% bone marrow blasts with at least one of the following:
- •Second or later bone marrow relapse;
- •Any marrow relapse after allogeneic hematopoietic stem cell transplant (alloHSCT);
- •Refractory to other treatments:
- •For participants in first relapse: failure to achieve a complete remission (CR) following a full standard reinduction chemotherapy regimen
- •For participants who have not achieved a first remission, failure to achieve remission following a full standard induction regimen
- •Karnofsky performance status ≥ 50% for participants ≥ 16 years
- •Lansky performance status ≥ 50% for participants < 16 years
排除标准
- •- Evidence of current central nervous system (CNS) involvement by ALL. Participants with CNS disease at the time of relapse are eligible if CNS is successfully treated prior to enrollment.
- •Other Medical Conditions
- •Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy).
- •Isolated extramedullary (EM) disease.
- •Active malignancy other than ALL.
- •Burkitt's leukemia according to the World Health Organization (WHO) 2016 criteria.
- •Abnormal renal or hepatic function at screening as defined below:
- •Abnormal serum creatinine based on age/gender as described by Threshold Creatinine Values
- •Direct bilirubin > 1.5 mg/dl (25.6 μmol/L) at screening (unless related to Gilbert's or Meulengracht disease).
- •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.
- •Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive) or hepatitis C virus (HCV) (anti-HCV positive).
- •Known hypersensitivity to blinatumomab or any of the products or components of the blinatumomab formulation.
- •Prior/Concomitant Therapy
- •AlloHSCT within 12 weeks prior to start of protocol-specified therapy.
- •Active acute or chronic Graft-versus-Host-Disease (GvHD) requiring systemic treatment with immunosuppressive medication.
- •Radiotherapy within 2 weeks prior to start of protocol-specified therapy.
- •Immunotherapy (eg, rituximab) within 4 weeks prior to start of protocol-specified therapy. Prior failed cluster of differentiation 19 (CD19) directed therapy such as prior blinatumomab or CD19 chimeric antigen receptor T cells (CAR T cell) will be allowed (with demonstrated continued CD19+ expression) if treatment ended > 4 weeks prior to start of protocol-specified therapy.
- •Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy. With the exception of intrathecal chemotherapy and/or low dose maintenance therapy for example vinca alkaloids, mercaptopurine, methotrexate, or hydroxyurea or pre-phase chemotherapy and/or dexamethasone. Any low dose chemotherapy as stated above must be discontinued before starting pre-phase.
- •Prior/Concurrent Clinical Study Experience
- •- 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(ies). Other investigational procedures while participating in this study are excluded.
- •Other Exclusions
- •Female participants of childbearing potential with a positive pregnancy test assessed at Screening by a highly sensitive urine or serum pregnancy test.
- •Female participants who are breastfeeding or who plan to breastfeed while on study through 12 months after the last dose of protocol-required treatment with highest teratogenic risk.
- •Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 12 months after the last dose of protocol-required treatment with highest teratogenic risk.
- •Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 6 months after the last dose of protocol-required therapy with highest teratogenic risk.
- •Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
- •Female participants planning to become pregnant while on study through 12 months after the last dose of protocol-required treatment with highest teratogenic risk.
- •Male participants unwilling to abstain from donating sperm during treatment and for an additional 6 months after the last dose of protocol-required treatment with highest teratogenic risk.
研究组 & 干预措施
Blinatumomab
Experimental
Participants will receive up to 5 cycles of blinatumomab (cycle is 42 days), including a 28-day continuous intravenous infusion (CIVI) of blinatumomab and a 14-day treatment free interval.
干预措施: Blinatumomab (Drug)
结局指标
主要结局
Number of Participants with CR with Partial Recovery of Peripheral Blood Counts (CRh)
时间窗: Up to 84 days
Number of Participants with Complete Remission (CR)
时间窗: Up to 84 days
次要结局
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to approximately 240 days)
- Number of Participants with Serious TEAEs(Up to approximately 2 years)
- Relapse-Free Survival (RFS) Rate(Up to approximately 2 years)
- 100-day Mortality Rate After alloHSCT(Up to approximately 2 years)
- Steady State Concentration (Css) of Blinatumomab(Days 3, 8, 9 and 29)
- Overall Survival (OS) Rate(Up to approximately 2 years)
- Number of Participants who Receive Allogeneic Hematopoietic Stem Cell Transplant (alloHSCT)(Up to approximately 2 years)
- Number of Participants with Anti-blinatumomab Antibody (ADA) Formation(Up to approximately 240 days)
- Minimal Residual Disease (MRD) Response(Up to 84 days)
- Number of Participants with Treatment-related TEAEs(Up to approximately 240 days)
- Clearance of Blinatumomab(Days 3, 8, 9 and 29)
- Number of Participants with Adverse Events of Interest(Up to approximately 240 days)
研究者
研究点 (7)
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