EUCTR2018-003465-33-PL进行中（未招募）1 期
Acalabrutinib in CLL and MCL patients subjected to allogeneic hematopoietic stem cell transplantation (alloSCT). - PLRG12
Polish Lymphoma Research Group - PLRG0 个研究点目标入组 40 人开始时间: 2019年1月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Relapsing / refractory BTK-inhibitors naïve CLL patients meeting IWCCL criteria for requiring treatment:
- •a. after 1-4 therapy lines if del 17 or p53 mutation in >10% of analyzed CLL cells (PB or BM) or
- •b. after 2-4 therapy lines if high risk CLL (refractory or less than 24 months response to the last immunochemotherapy) or
- •2. Relapsing / refractory BTK-inhibitors naïve MCL patients with measurable disease or bone marrow involvement revealed in trephine biopsy or
- •3. Patients fulfilling criteria 1 or 2, when ibrutinib therapy was initiated, responding to therapy
- •4. Patient qualified for allo SCT procedure by the transplant center participating in the trial with identified sibling donor or initiated Poltransplant search for matched unrelated donor.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •6. Men and women = 18 years of age.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Patients failing 5 or more previous therapy lines
- •2. Prior malignancy (or any other malignancy that requires active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for = 5 years
- •3. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification (NYHA). Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study.
- •4. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
- •5. Impaired hepatic function (as indicated by any of the following):
- •a. Serum total bilirubin > 2.5 x upper limit of normal (ULN)
- •b. Alanine amino transferase and/or aspartate amino transferase > 2.5 x ULN
- •c. Alkaline phosphatase > 2.5 x ULN
- •6. Impaired renal function: serum creatinine > 2.5 x ULN
- •7. Other concurrent serious diseases that increase Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) > 4
- •8. Central nervous system involvement with CLL
- •9. Active bleeding, history of bleeding diathesis (eg, hemophilia or von Willebrand disease).
- •10. Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura).
- •11. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.
- •12. Requiring or receiving a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer (see appendix 3 for a complete list)
- •13. Requiring or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug.
- •14. Requiring proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study.
- •15. Prothrombin time/INR or aPTT (in the absence of Lupus anticoagulant) > 2x ULN.
- •16. History of significant cerebrovascular disease or event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug.
- •17. Major surgical procedure within 30 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug.
- •18. Known history of infection with HIV or any active uncontrolled systemic infection
- •19. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded.
- •Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded.
- •20. ANC < 500/µl, Platelets < 20 000/µl, and hemoglobin < 8 g/dl
- •21. Breastfeeding or pregnant.
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