NL-OMON39852CompletedPhase 2
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)
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 4
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •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 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 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 or peripheral blood 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
- •11. Ability to understand and willingness to sign a written informed consent
- •12. Signed and dated written informed consent is available
Exclusion Criteria
- •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.
Investigators
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