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 - MT103-203

Micromet AG0 sites130 target enrollmentSeptember 16, 2010

Overview

No summary available.

Registry

who.int

Start Date

September 16, 2010

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•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, induc\-tion/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 sensitivity and a lower level of quantification 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 indi\-vidual 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 specimen from primary diagnosis (a sufficient amount of DNA (30µg) or a respective amount of cell material) for clone\-specific MRD assessment must be received by central MRD lab and lab must con\-firm that the sample is available
•5\. Bone marrow function as defined in the protocol
•6\.Renal and hepatic function as defined in the protocol
•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\. equal or older 18 years

•1\. Presence of circulating blasts or current extra\-medullary involvement by ALL
•2\. History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cere\-brovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
•3\. Current infiltration of cerebro\-spinal 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