EUCTR2013-000536-10-DE进行中（未招募）1 期
A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE® Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study) - TOWER Study
Amgen Inc.0 个研究点目标入组 400 人开始时间: 2013年9月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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. Subjects with Philadelphia negative B-precursor ALL, with any of the following:
- •- refractory to primary induction therapy or refractory to salvage therapy,
- •- in untreated first relapse with first remission duration <12 months
- •- in untreated second or greater relapse
- •- or relapse at any time after allogeneic HSCT
- •2. Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.
- •3. Greater than 5% blasts in the bone marrow
- •4. Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •5. Age = 18 years at the time of informed consent
- •6. 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 308
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 92
排除标准
- •1. History of malignancy other than ALL within 5 years prior to start of protocol-specified 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. Diagnosis of Burkitt´s Leukemia according to WHO classification
- •3. 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 with the exception of history of CNS leukemia that is controlled with intrathecal therapy
- •4. Active ALL in the CNS (confirmed by CSF analysis) or testes (no clinical sign thereof)
- •5. Isolated extramedullary disease
- •6. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- •7. Autologous HSCT within 6 weeks before the start of protocol-specified therapy
- •8. Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy
- •9. Any active acute Graft-versus-Host Disease (GvHD), grade 2-4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment
- •10. Any systemic therapy against GvHD within 2 weeks before start of protocol-specified therapy
- •11. Known exclusion criteria to investigator choice of SOC chemotherapy (as per product insert).
- •12. Cancer chemotherapy within 2 weeks before start of protocol-specified therapy (intrathecal chemotherapy and dexamethasone are allowed until start of protocol-specified therapy). In addition, any subject whose organ toxicity (excluding hematologic) from prior ALL treatment has not resolved to no more than CTCAE grade 1
- •13. Radiotherapy within 2 weeks before the start of protocol-specified therapy
- •14. Immunotherapy (e.g., rituximab) within 4 weeks before start of protocol-specified therapy
- •15. Subject received prior anti-CD19 therapy
- •4.2.16 Abnormal screening laboratory values as defined below:
- •- AST (SGOT) and/or ALT (SGPT) and/or ALP = 5 x upper limit of normal (ULN)
- •- Total bilirubin (TBL) = 1.5 x ULN (unless related to Gilbert´s or Meulengracht disease)
- •- Creatinine = 1.5 ULN or Creatinine clearance < 60 ml/min (calculated)
- •17. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive)
- •18. Subject is pregnant or breast feeding, or might become pregnant within 24 hours after the last dose of protocol-specified therapy
- •19. Woman of childbearing potential and is not willing to use 2 highly effective methods of contraception while receiving protocol-specified therapy and for an additional 24h after the last dose of protocol-specified therapy.
- •20. 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(s). Thirty days is calculated from Day 1 of protocol-specified therapy.
- •21. Other investigational procedures while participating in this study are excluded (except for particip
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