EUCTR2018-001850-80-SE进行中（未招募）1 期
Acalabrutinib and rituximab in elderly patients with untreated mantle cell lymphoma - ALTAMIRA
Skåne University Hospital0 个研究点目标入组 80 人开始时间: 2021年1月27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
- 80
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. Age =60 years
- •2. Pathologically confirmed MCL (according to the 2016 WHO classification),with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1
- •3. Stage II-IV, measurable by imaging and requiring treatment in the opinion of the treating clinician
- •4. No previous treatment for MCL (other than localised radiotherapy or 7 day pulse of steroids for symptom control)
- •5. ECOG performance status 0 – 2
- •6. Absolute neutrophil count (ANC) >1.0x 109 and platelet count >100 x 109, unless related to lymphoma - in this situation, the threshold for inclusion is ANC >0.5x 109 and platelet count >50 x 109
- •7. Creatinine clearance >30 ml/min (Cockcroft-Gault)
- •8. AST and/or ALT <3xULN and/or total bilirubin <3xULN
- •9. Able to give voluntary written informed consent
- •10. Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and for 2 days after the last dose of acalabrutinib or for 12 months after last dose of rituximab, whichever is longer.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Patients considered fit enough to undergo autologous or allogeneic stem cell transplant for MCL
- •2. Major surgery within two weeks prior to day 1 of cycle 1
- •3. Patients who are unable to swallow capsules, or who have disease significantly affecting gastrointestinal function that would limit oral absorption of medication.
- •4. Known serological positivity for HBV, HCV, HIV. Patients 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) result. Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Patients who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded.
- •5. Diagnosed with or treated for any other malignancy than MCL within 2 years prior to day 1 of cycle 1 (except basal cell carcinoma, cutaneous squamous cell carcinoma or any other in situ malignancy)
- •6. Active infection requiring treatment
- •7. Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •8. Concurrent treatment with another investigational agent outside of this protocol
- •9. Known history of drug-specific hypersensitivity or anaphylaxis to rituximab or acalabrutinib (including active product or excipient components).
- •10. Active bleeding, history of bleeding diathesis (eg, hemophilia or von Willebrand disease).
- •11. Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura).
- •12. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited
- •13. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug.
- •14. Prothrombin time/INR or aPTT (in the absence of Lupus anticoagulant) > 2x ULN.
- •15. Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Patients receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study.
- •16. History of significant cerebrovascular disease or event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug.
- •17. Breastfeeding or pregnant women
- •18. Concurrent participation in another therapeutic clinical trial.
- •19. History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)
- •20. Significant cardiovascular disease such as symptomatic arrhytmias, 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 as Screening. Note: Subjects with controlled asymptomatic atrial fibrillation are allowed to enroll on study
- •21. Received a live virus vaccination within 28 days of first dose of study drug
研究者
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