EUCTR2010-018314-75-DE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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 116
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 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. History of malignancy other than ALL within five years prior to treatment start with blinatumomab, 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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