KCT0003724招募中未知
Phase II trial of Acalabrutinib with rituximab and lenalidomide in relapsed/refractory B-cell non-Hodgkin lymphoma
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 66
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 aggressive B-cell non-hodgkin lymphoma
- •- diffuse large B-cell lymphoma(germinal center B-cell-like subtype and non- germinal center B-cell-like subtype both
- •: germinal center B-cell-like subtypes shall not be less than 40%(Number: 26) of the total study population(germinal center B-cell-like subtype patients will be limited to a maximum of 26)
- •- Mediastinal large B-cell lymphoma
- •- Transformed follicular lymphoma
- •- Small lymphocytic lymphoma with Richter transformation
- •3. The previous treatment fails and the last infusion of treatment must be two weeks ahead of the time of enrollment.
- •- Should have received anti-CD20 based chemotherapy previously.
- •- Fail to at least two lines of therapy if patient is candidate for autologous stem cell transplantation
- •- Fail to frontline therapy if patient is ineligible for autologous stem cell transplant
- •4. Eastern Cooperative Oncology Group performance status 0, 1 or 2
- •5. A fertile woman with sexual function should conduct two tests of urine human chorionic gonadotropin before administering the investigational product and then start the test for one week each week, and then every four weeks after that, if her menstrual period is irregular, she should be tested. Test of urine human chorionic gonadotropin shall be carried out up to 4weeks after final administration of acalabrutinib, lenalidomide and rituximab. A female of childbearing potential should use two methods of contraception including at least one highly effective contraception method, for four weeks before the first treatment, four weeks after the last administration of acalabrutinib and lenalidomide, and 12 months after the last administration of Rituximab. Sexual active men should use condoms during treatment and for 4weeks after the last administration of investigational product.
- •6. Capsule swallowing is possible, and is willing and willing to participate in all the assessments and procedures required by this protocol.
- •7. It may be permitted to understand the objectives and risks of the study and to use its own medical information for the purposes of the study.
排除标准
- •1. Mantle cell lymphoma
- •2. In case of more than 5 treatments have previously failed (the hematopoietic transplant is determined by one treatment)
- •3. In case of patients previously treated with allogeneic hematopoietic stem cell transplantation with 6 months
- •4. In case of patients with active Graft versus host disease requiring treatment
- •5. In case oral medication is not available
- •6. If you have previously been treated with Bruton’s Tyrosine Kinase inhibitors and lenalidomide treatment, both drugs have a progression free survival rate of less than 6 months, or if you have a Bruton’s Tyrosine Kinase protein C481S, or PLGC R665W variable
- •7. 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)
- •8. 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
- •9. Surgical history of gastrointestinal diseases, inflammatory intestinal diseases, intestinal obstruction and intestinal bypasses that are so severe as to impair absorption
- •10. Human immunodeficiency virus positive or has other uncontrolled active infections
- •11. In case of active tuberculosis, in case of latent tuberculosis requiring treatment
- •12. Hepatitis B virus carrier, or if your blood test indicates that you have a positive anti-B hepatitis core antibody immunoglobulin G, you will be positive for the polymerase chain reaction of hepatitis B virus, hepatitis C virus carrier
- •13. In case of Life-threatening hypersensitivity or anaphylaxis disease for the drugs included in this clinical study
- •14. In case of uncontrolled active bleeding or a history of a condition that tends to bleed
- •15. In case of uncontrolled autoimmune hemolytic anemia or Idiopathic thrombocytopenic purpura
- •16. In case of a need to take the prohibited medication (CYP3A4 inhibitor/derived drug), Proton pump inhibitor or warfarin or equivalent vitamin K antagonist specified in the protocol
- •17. In case of a major operation within the last 28 days, or failure to recover after the operation
- •18. White blood cell <3,000 /µL, Absolute Neutrophil Count < 1,000 /µL, Platelet < 75,000 /µL, or Hemoglobin < 9.0 g/dL(When observed without blood transfusion within 2 weeks)
- •19. Total bilirubin > 2 times upper limit of normal , or aspartate aminotransferase, alanine aminotransferase > 3 times upper limit of normal
- •20. Prothrombin time/ international normalized ratio or activated partial thromboplastin time (in the absence of Lupus anticoagulant) > 2 times upper limit of normal
- •21. Serum creatinine > 1.5 times upper limit of normal or Creatinine Clearance < 30 mL/min/1.73m2
- •22. Female who is currently pregnant or breast feeding
- •23. Currently registered in other therapeutic clinical studies for the treatment of lymphoma
研究者
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