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

Amgen Research (Munich) GmbH0 个研究点目标入组 116 人开始时间: 2010年4月29日最近更新: 2022年1月24日

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•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)

•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

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