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 - MT 103-203
- Conditions
- Patient with Minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemiaMedDRA version: 9.1Level: LLTClassification code 10000845
- Registration Number
- EUCTR2010-018314-75-IT
- Lead Sponsor
- MICROMET AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 116
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 (30?g) 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 below: - ANC (Neutrophils)= 1 000/µL - Platelets = 50.000/µL (transfusion permitted) - HB level = 9g/dl (transfusion permitted) 6.Renal and hepatic function as defined below: - AST (GOT), ALT (GPT), and AP < 2 x upper limit of normal (ULN) - Total bilirubin < 1.5 x ULN - Creatinine 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
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 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 dur-ing 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method