Blinatumomab for minimal residual disease before hematopoietic stem cell transplantation in pediatric B-cell precursor
- Conditions
- Neoplasms
- Registration Number
- KCT0006135
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
1. Immunophenotypic evidence of Cluster of Differentiation 19 (CD19) positive B precursor ALL
2. Age =18 years at the time of informed consent/assent
3. B cell precursor ALL in first or later hematologic complete remission (CR) defined as less than 5% blasts in bone marrow after at least three intense chemotherapy blocks
4. Confirmed MRD positivity before hematopoietic stem cell transplantation
5. Bone marrow function as defined below [Absolute neutrophil count =1,000/µL, Platelets =50,000/µL (transfusion permitted), Hemoglobin level =9 g/dL (transfusion permitted]
6. Renal and hepatic function as defined below (AST, ALT, and AP < 2 x upper limit of normal (ULN), Total bilirubin <1.5 x ULN, Creatinine clearance =50mL/min)
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. Performance status: Karnofsky or Lansky score =70 for subjects =16 years old or <16 years old, respectively
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, epilepsy, paresis, aphasia, stroke, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis) with the except of CNS leukemia that is well controlled with intrathecal therapy
3. Current infiltration of cerebrospinal fluid by ALL
4. History of or active relevant autoimmune disease
5.Systemic cancer chemotherapy within 2 weeks prior to study treatment (except for intrathecal prophylaxis)
6.Radiotherapy within 4 weeks prior to study treatment
7.Autologous HSCT within six weeks prior to study treatment
8.Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
9.Treatment with any investigational product within 4 weeks prior to study treatment
10.Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
11.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
12.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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of treatment-emergent and treatment-related adverse events
- Secondary Outcome Measures
Name Time Method Complete MRD response status after 1 cycle of blinatumomab;Hematologic Relapse-Free Survival (RFS);Overall Survival (OS)