2023-509864-96-00招募中2 期
Acalabrutinib and rituximab in elderly patients with untreated mantle cell lymphoma (ALTAMIRA)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 80
- 试验地点
- 17
- 主要终点
- Progression-free survival. This is defined as the interval between date of obtaining informed consent and date of documented progression, first relapse, or death of any cause. Otherwise, patients will be censored at the last date they were known to be alive.
研究概览
简要总结
To evaluate progression-free survival with acalabrutinib-rituximab in patients with untreated mantle cell lymphoma, compared to data from the NLG-MCL4 trial.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years
- •Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception (see appendix 2) during treatment and for 2 days after the last dose of acalabrutinib or for 12 months after last dose of rituximab, whichever is longer
- •Pathologically confirmed MCL (according to the WHO 2016 classification), with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1
- •Stage II-IV, measurable by imaging and requiring treatment in the opinion of the treating clinician
- •No previous treatment for MCL (other than localised radiotherapy or 7-day pulse of steroids for symptom control)
- •ECOG performance status 0 – 2
- •Absolute neutrophil count (ANC) > 1.0 x 10^9 and platelet count > 100 x 10^9, unless related to lymphoma - in this situation, the threshold for inclusion is ANC >0.5 x 10^9 and platelet count > 50 x 10^9
- •Creatinine clearance >30 ml/min (Cockcroft-Gault)
- •AST and/or ALT <3x ULN and/or P-bilirubin <3x ULN
- •Able to give voluntary written informed consent
排除标准
- •Patients considered fit enough to undergo autologous or allogeneic stem cell transplant for MCL
- •Active bleeding, history of bleeding diathesis (eg, hemophilia or von Willebrand disease)
- •Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura)
- •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
- •Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug.
- •Prothrombin time/INR or aPTT (in the absence of Lupus anticoagulant) > 2x ULN.
- •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
- •History of significant cerebrovascular disease or event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug
- •Breastfeeding or pregnant women
- •Concurrent participation in another therapeutic clinical trial
- •History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)
- •Major surgery within two weeks prior to day 1 of cycle 1
- •Significant cardiovascular disease such as 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 at Screening. Note: Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study
- •Received a live virus vaccination within 28 days of first dose of study drug
- •Patients who are unable to swallow capsules/tablets, or who have disease significantly affecting gastrointestinal function that would limit oral absorption of medication
- •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
- •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)
- •Active infection requiring treatment
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •Concurrent treatment with another investigational agent outside of this protocol
- •Known history of drug-specific hypersensitivity or anaphylaxis to rituximab or acalabrutinib (including active product or excipient components)
结局指标
主要结局
Progression-free survival. This is defined as the interval between date of obtaining informed consent and date of documented progression, first relapse, or death of any cause. Otherwise, patients will be censored at the last date they were known to be alive.
Progression-free survival. This is defined as the interval between date of obtaining informed consent and date of documented progression, first relapse, or death of any cause. Otherwise, patients will be censored at the last date they were known to be alive.
次要结局
- Complete response rate at 6 months
- Molecular remission rate (MRR) by PCR
- Overall response rate
- Progression-free survival (median)
- Response duration (median)
- Duration of molecular remission (median)
- Overall survival (median)
- CR, MRR and ORR in TP53-mutated MCL
- Safety, in terms of all grade 3-5 AE
研究者
Mats Jerkeman
Scientific
Region Skane
研究点 (17)
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