EUCTR2010-018314-75-CZ进行中（未招募）1 期
A confirmatory 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 lymphoblastic leukemia - BLAST MT103-203
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
入选标准
- •1. Patients with 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, induction/intensification/ consolidation or three blocks of Hyper CVAD)
- •2. Presence of minimal residual disease at a level of =10-3 (molecular failure or molecular relapse) in an assay with a minimum sensitivity of 10-4 documented after an interval of at least 2 weeks from last systemic chemotherapy
- •3. For evaluation of minimal residual disease, patients must have at least one molecular marker based on individual rearrangements of immunoglobulin or TCR-genes or a flow cytometric marker profile, evaluated by a national or local reference lab approved by the Sponsor
- •4. Bone marrow or peripheral blood specimen from primary ALL diagnosis /diagnosis of ALL relapse (a sufficient amount of DNA or a respective amount of cell material) for clone-specific MRD assessment must be received by central MRD lab and lab must confirm that the sample is available
- •5. Bone marrow function as defined in the protocol
- •-ANC (Neutrophile) = 1 000/µL
- •-Thrombozyten = 50,000/µL (transfusion permitted)
- •-HB Level = 9g/dl (transfusion permitted)
- •6. Renal and hepatic function as defined in the protocol
- •-AST (GOT), ALT (GPT), und AP < 2 x upper limit of normal (ULN)
- •-Total bilirubin < 1.5 x ULN
- •-Creatinin-Clearance = 50 mL/min (e.g. calculated according Cockroft & Gault)
- •7. Negative HIV test, negative hepatitis B (HbsAg) and hepatitis C virus (anti-HCV) test
- •8. Negative pregnancy test in women of childbearing potential
- •9. ECOG Performance Status 0 or 1
- •10. Age =18 years
- •11. Ability to understand and willingness to sign a written informed consent
- •12. Signed and dated written informed consent is available
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Presence of circulating blasts or current extramedullary involvement by ALL
- •2. History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
- •3. Current infiltration of cerebrospinal fluid by ALL
- •4. History of or active relevant autoimmune disease
- •5. Prior allogeneic HSCT
- •6. Eligibility for treatment with TKIs (i.e., Philadelphia chromosome-positive (Ph) patients with no documented treatment failure of or intolerance/contraindication to at least 2 TKIs)
- •7. Systemic cancer chemotherapy within 2 weeks prior to study treatment, (except for intrathecal prophylaxis)
- •8. Radiotherapy within 4 weeks prior to study treatment
- •9. Autologous hematopoietic stem cell transplantation (HSCT) within six weeks prior to study treatment
- •10. Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
- •11. Treatment with any investigational product within four weeks prior to study treatment
- •12. Previous treatment with blinatumomab
- •13. Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
- •14. Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
- •15. 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
- •16. Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.
研究者
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