KCT0005350尚未招募未知
Phase II trial of Rituximab preconditioning for relapsed/refractory Philadelphia negative B-cell acute lymphoblastic leukemia treated with blinatumomab
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
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