None listed
Conditions
Interventions
Drug : According to random assignment, the treatment arm and control arm are divided into
Treatment arm : Rituximab intravenous injection, 375mg/m2, 7days~2days prior to the administration of blinatumomab
Control arm : Only blinatumomab intravenous injection, standard dose and usage
28 da
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age more than 19 years old 2. Diagnosis with Philadelphia negative B-cell acute lymphoblastic leukemia 3. Previous treatment failures and more than two weeks from last dose to enroll date - Should have previously treated an anthracycline-based chemotherapy - Failure of first or secondary chemotherapy 4. Eastern Cooperative Oncology Group performance status 0, 1 or 2 5. Women of childbearing potential should get negative results from urine human chorionic gonadotropin tests before first administering the investigational product. The subject should use two methods of contraception including at least one highly effective contraception method, for four weeks before the first treatment, 12 months after the last administration of Rituximab. 6. Capsule swallowing is possible, and is willing and willing to participate in all the assessments and procedures required by this protocol 7. Pre-processed bone marrow aspiration biopsy with CD20 positive 5% or higher 8. Ability to understand the objectives and risks of the study and to sign and approve dated prior consent to use protected medical information
Exclusion criteria
Exclusion criteria: 1. Diagnosis with Philadelphia positive B-cell acute lymphoblastic leukemia 2. In case of previous 3 or more induced chemotherapy (consolidated hematopoietic stem cell transplantation is considered the same order therapy) 3. In case of patients previously treated with allogeneic hematopoietic stem cell transplantation with 3 months 4. In case of patients with active Graft versus host disease requiring treatment 5. In case of other neoplastic disease other than B cell non-Hodgkin lymphoma within 5 years (except for cervical carcinoma, skin squamous cell carcinoma with simple excision) 6. There were clinically significant cardiovascular disorders (uncontrolled arrhythmia, heart failure, cardiac infarction) within 6 months, or there were cardiovascular disorders clinically significant (brain infarction, cerebral hemorrhage) corresponding to the category 3 or 4 of the New York Heart Association Functional Classification of Cardiology 7. Human immunodeficiency virus positive or has other uncontrolled active infections(e.g. bacteria, viruses, or fungi) 8. Drug hypersensitivity to Rituximab or anaphylaxis history (including active products or additives) 9. Hypersensitive history of other components of immunoglobulin or investigational product formulation 10. In case of active bleeding or a history of a condition that tends to bleed(e.g. hemophilia or Ponvillebrandt disease) 11. Gastrointestinal ulcer diagnosed in endoscopy within 3 months prior to screening 12. Absolute Neutrophil Count < 1,000 /µL, Platelet < 75,000 /µL 13. Prothrombin time/ international normalized ratio or activated partial thromboplastin time (in the absence of Lupus anticoagulant) > 2 times upper limit of normal 14. Any history of the associated central nervous system pathology within or as of the first 6 months of taking the study drug(e.g. seizures, paralysis, aphasia, cerebral vascular ischemia/bleeding, severe brain damage, dementia, Parkinson's disease, cerebellar disease, substrate brain syndrome, psychosis, coordination or motor disorder) 15. Acute lymphoblastic leukemia involve of cerebrospinal fluid 16. In case of an uncontrolled severe immune disorder, such as past or present related autoimmune diseases 17. History of important brain vascular diseases or events, including strokes or intracranial bleeding, within 6 months before the first dose of the study drug. 18. In case of a major operation within the last 28 days : If the patient has undergone major surgery, it should be properly recovered from toxicity and/or complications caused by intervention prior to the first dose of the study drug 19. Serum condition of hepatitis B or C : hepatitis B core antibody positive and B surface antigen negative should confirm that hepatitis B virus polymerase chain reaction is negative. Except in case of positive surface antigen B or positive hepatitis B virus polymerase chain reaction. If hepatitis B core antibody positive and hepatitis B surface antigen, hepatitis B virus polymerase chain reaction negative, proper virus preventive treatment should be taken during the study period. 20. Patients with hepatitis C antibody positive need negative hepatitis virus polymerase chain reaction results. Except for those who are positive for hepatitis C virus polymerase chain reaction. 21. Total bilirubin > 3 times upper limit of normal , or aspartate aminotransferase, alanine aminotransferase > 3 times upper limit of normal 22. Serum creatinine > 1.5 times upper
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate (including Complete remission with incomplete blood count recovery,Complete remission with incomplete platelet recovery) | — |
Secondary
| Measure | Time frame |
|---|---|
| Minimal residual disease rate;Duration of response;Progression free survival rate;Overall survival rate;Treatment-emergent adverse event, Serious adverse events, side effects requiring discontinuation of investigational product | — |
Countries
Korea, Republic of
Contacts
Public ContactYoungil Koh
Seoul National University Hospital
Outcome results
None listed