EUCTR2019-004780-52-AT进行中（未招募）1 期
A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of adults with Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-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
- 入组人数
- 130
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
- 性别
- All
入选标准
- •101 Subject has provided informed consent prior to initiation of any study specific activities/procedures and/or the subject’s legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
- •102 Age = 18 years at time of informed consent
- •For disease status: subjects in dose escalation and dose expansion (cohorts Ph2a1 to Ph2a4) must fulfill at least 1 of inclusion criteria 103, 104, or 105 for eligibility.
- •Cohort Ph2b only:Subjects will be eligible if they have B-ALL and meet the MRD criteria defined in inclusion criterion #109 below. Subjects with R/R B-ALL in CR (<5% BMB) who meet criteria for MRD will be eligible for cohort Ph2b. With the exception of disease status criteria (ie, inclusion criteria #103, #104, #105, #106), Ph2b cohort subjects must satisfy all other inclusion criteria to be eligible.
- •103 Subjects with B-precursor ALL with any of the following:
- •Either Refractory (to primary induction) therapy or refractory to at least 1 salvage therapy OR
- •In untreated first, second, third or greater relapse or refractory relapse:
- •- First Relapse is defined achievement of first CR (CR1) during upfront therapy then relapse during or after continuation therapy
- •- Primary Refractory disease is defined as the absence of CR after standard induction therapy.
- •- Refractory relapse is defined as lack of CR after salvage treatment
- •- Second relapse or later relapse is defined as relapse after achieving a second CR (CR2) in first or later salvage
- •- Refractory to salvage is defined as no attainment of CR after salvage
- •104 Relapsed or Refractory at any time after first salvage therapy
- •105 Relapse at any time after allogenic HSCT.
- •106 Greater than or equal to 5% blasts in the BM
- •107 Eastern Cooperative Oncology Group (ECOG) Performance Status = 2.
- •108 Subjects with relapse or refractory B Cell ALL Ph+ disease and that are intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.
- •109 For subjects in the dose expansion MRD cohort only (cohort Ph2b), BMB must be <5% and =0.1%. This will replace inclusion criterion #106 for subjects in this cohort
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 107
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Disease Related
- •- Active ALL in the CNS. Presence of > 5 white blood cells (WBC) per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblasts present (confirmed by CSF analysis) and or clinical signs of CNS leukemia. If CSF leukemia is present subjects will have to receive intrathecal therapy and have documented negative CSF prior to enrolling.
- •Other Medical Conditions
- •- History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome or psychosis.
- •- Isolated extramedullary (EM) disease.
- •- Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
- •- Active acute or chronic graft versus host disease requiring systemic treatment with immunosuppressive medication.
- •- Known hypersensitivity to blinatumomab or to any component of the product formulation.
- •- Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus.
- •- 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.
- •- Testicular leukemia.
- •- History of malignancy other than ALL within 3 years prior to start of protocol-specified therapy except for:
- •Malignancy treated with curative intent and with no known active disease present for 3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
- •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- •Adequately treated cervical carcinoma in situ without evidence of disease.
- •Adequately treated breast ductal carcinoma in situ without evidence of disease.
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer.
- •Prior/Concomitant Therapy
- •- Allogeneic HSCT within 12 weeks before the 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 (any low dose chemotherapy as stated above must be discontinued before starting pre-phase) or pre-phase chemotherapy and/or dexamethasone.
- •- Immunotherapy (eg, rituximab, alemtuzumab) within 4 weeks before start of protocol-specified therapy. Prior failed CD19 directed therapy such as prior blinatumomab or CD19 CAR T cells will be allowed (with demonstrated continued CD19+ expression), if treatment ended > 4 weeks prior to start of protocol therapy.
- •Prior/Concurrent Clinical Study Experience
- •- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational studies are not permitted while participating in this study.
- •Diagnostic Assessments
- •- Abnormal screening laboratory values as defined below:
- •Total bilirubin >3.0 mg/dL prior to start of treatment (unless related to Gilbert’s or Meulengracht disease)
- •Estimated Creatinine clearance < 60 mL/min
- •Other Exclusions
- •- Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an
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