EUCTR2015-000733-76-DE进行中（未招募）1 期
A multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE® antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lympho-blastic leukemia (Blast Successor Trial)
Goethe-Universität Frankfurt, Universitätsklinikum, Med. Klinik II0 个研究点目标入组 80 人开始时间: 2016年3月2日最近更新:
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
- 入组人数
- 80
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 CD19 positive B–precursor ALL in complete hematological remission defined as less than 5% blasts in bone marrow after at least three intense chemotherapy blocks (e.g., GMALL induction I-II/consolidation I).
- •2.Presence of minimal residual disease (MRD) after an interval of at least 8 days from last systemic chemo-therapy
- •at a level of =10-4 - <10-3 (molecular failure or molecular relapse) in an assay with a minimum sensitivity of 10-4 OR
- •at levels below 10-4 :
- •oPositive <10-4, non quantifiable (MolNE1) OR
- •oPositive <10-4 (MolNE2) OR
- •Presence of minimal residual disease (MRD), non quantifiable (MolNE3).
- •3. For evaluation of MRD patients must have at least one molecular marker based on individual rearrange-ments of immunoglobulin, TCR-genes or other suitable genes evaluated by the reference laborabory of the trial
- •4. Bone marrow function as defined below:
- •- ANC (Neutrophils) >/= 1,000/µL
- •- Platelets >/= 50,000/µL (transfusion permitted)
- •- HB level >/= 9g/dl (transfusion permitted)
- •5. Renal and hepatic function as defined below:
- •- AST (GOT), ALT (GPT), and AP < 5 x upper limit of normal (ULN)
- •- Total bilirubin < 1.5 x ULN (unless related to Gilbert's Meulen-gracht disease)
- •- Creatinine < 1.5x ULN
- •- Creatinine clearance >/= 60 mL/min (e.g. calculated according Cockroft & Gault)
- •6. Negative HIV test, negative hepatitis B (HbsAg) and hepatitis C virus (anti-HCV) test
- •7. Negative pregnancy test in women of childbearing potential
- •8. ECOG Performance Status 0 or 1
- •9. Age min. 18 years
- •10. Ability to understand and willingness to sign a written informed consent
- •11. Signed and dated written informed consent is available
- •12. Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)
- •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 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. Ph/BCR-ABL positive ALL
- •2. Presence of circulating blasts or current extramedullary involvement by ALL
- •3. History or presence of clinically relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome or psychosis)
- •4. Current detection of ALL blast cells in cerebrospinal fluid
- •5. History of or active relevant autoimmune disease
- •6. Systemic cancer chemotherapy within 2 weeks prior to study treatment (except for intrathecal prophylaxis)
- •7. Radiotherapy within 4 weeks prior to study treatment
- •8. Live vaccination within 2 weeks before the start of study treatment
- •9. Autologous hematopoietic stem cell transplantation (SCT) within six weeks prior to study treatment
- •10. Allogeneic SCT within 12 weeks before the start of study treatment
- •11. Any active acute Graft-versus-Host Disease (GvHD), grade 2-4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment
- •12. Any systemic therapy against GvHD within 2 weeks before start of study treatment
- •13. Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
- •14. Treatment with any investigational product within four weeks prior to study treatment
- •15. Previous treatment with blinatumomab or other anti-CD19-therapy
- •16. Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
- •17. History of malignancy other than ALL diagnosed within 5 years prior to start of protocol-specified therapy with the exception of:
- •- 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
- •18. Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
- •19. Nursing women
- •20. Woman of childbearing potential and is not willing to use a highly effective method of contraception while receiving study treatment and for an additional 3 months after the last dose of study treatment.
- •21. Male who has a female partner of childbearing potential, and is not willing to use a highly effective form of contraception while receiving study treatment and for at least an additional 3 months after the last dose of study treatment
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