EUCTR2013-000706-36-GB进行中（未招募）1 期
A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE® Antibody Blinatumomab in Adult Subjects with Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study) - Alcantara Study
Amgen Inc.0 个研究点目标入组 45 人开始时间: 2013年10月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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. Patients with Ph+ B-precursor ALL, with any of the following:
- •Relapsed or refractory to at least one second generation TKI (dasatinib, nilotinib, bosutinib, ponatinib)
- •OR intolerant to second generation TKI and intolerant or refractory to imatinib mesylate
- •2. Greater than 5% blasts in bone marrow
- •3. Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •4. Age = 18 years of age, at the time of informed consent
- •5. Subject has provided informed consent or subject’s legally acceptable representative has provided informed consent 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.
- •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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •1. History of malignancy other than ALL within 5 years prior to start of protocol-required therapy with the exception of:
- •- Malignancy treated with curative intent and with no known active disease present for 5 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
- •2. History or presence of clinically relevant CNS pathology as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis
- •- With the exception of CNS leukemia that is well controlled with intrathecal therapy
- •3. Active ALL in the CNS (confirmed by CSF analysis) or testes (no clinical sign thereof)
- •4. Isolated extramedullary disease
- •5. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- •6. Allogeneic HSCT within 12 weeks prior to start of blinatumomab
- •7. 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
- •8. Any systemic therapy against GvHD within 2 weeks prior to start of blinatumomab
- •9. Cancer chemotherapy within 2 weeks prior to start of blinatumomab (exceptions: prior TKI therapy is allowed but must be completed prior to start of blinatumomab; prophylactic intrathecal chemotherapy and prephase dexamethasone are allowed until start of blinatumomab). In addition, any subject whose organ toxicity (excluding hematologic) from prior ALL treatment has not resolved to no more than CTCAE grade 1.
- •10. Immunotherapy (eg, rituximab) within 4 weeks prior to start of blinatumomab
- •11. Subject received prior anti-CD19 therapy
- •12. Eligibility for alloHSCT at the time of enrollment (as defined by disease status, performance status and availability of donor)
- •13. Abnormal screening laboratory values as defined below:
- •- AST (SGOT) and/or ALT (SGPT) and/or alkaline phosphatase = 5 x upper limit of normal (ULN)
- •- Total bilirubin = 1.5 x ULN (unless related to Gilbert´s or Meulengracht disease)
- •- Creatinine = 1.5 ULN or creatinine clearance < 60 mL/min (calculated)
- •14. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive).
- •15. Subject is pregnant or breast feeding, or might become pregnant within 3 months after the last dose of protocol-specified therapy
- •16. Woman of childbearing potential and is not willing to use 2 highly effective methods of contraception while receiving blinatumomab and for an additional 3 months after the last dose of protocol-specified therapy
- •17. Male who has a female partner of childbearing potential, and is not willing to use 2 highly effective forms of contraception for at least an additional 3 months after the last dose of protocol-specified therapy
- •18. Male who has a pregnant partner, and is not willing to use a condom during sexual activity for 3 months after the last dose of protocol-specified therapy
- •19. Currently receiving treatment in another investigational device or drug study or less than 30 days s
研究者
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