NCT05222269终止2 期
A Prospective, International, Multi-centre, Open-label, Single-arm Phase II Study Investigating the Predictive Value of [68Ga]Ga PentixaFor PET Imaging in Primary and Isolated Secondary CNS Lymphoma Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Negative predictive value (NPV) of interim 68Ga-PTF-PET (after 6 ± 2 weeks of induction chemotherapy) for progression-free survival (PFS)
研究概览
简要总结
This will be an open, single-arm, international, multicentre, phase II imaging study to assess the predictive value of [68Ga]Ga PentixaFor PET imaging in primary and isolated secondary central nervous system lymphoma (CNSL) patients scheduled to undergo induction chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained according to international guidelines and local laws by patient (or legally acceptable representative, if the patient is temporarily legally not competent owing to his/her disease). [Note: No invasive study-specific procedures may be carried out until this consent has been given.]
- •Patient aged 18 years or above (either sex).
- •Histologically confirmed primary or secondary CNSL based on cytology/flow cytometry of cerebrospinal fluid (CSF) or brain biopsy.
- •Disease exclusively located in the CNS (primary CNSL or secondary CNSL with isolated CNS relapse). Subjects who had undergone allogeneic stem cell transplant > 12 months prior to first dose of study drug, have no evidence of active graft versus host disease, and are not on systemic immunosuppressive therapy are allowed to participate in the study.
- •At least one measurable parenchymal lesion. [Note: parenchymal CNSL is a "must", and additional locations such as leptomeningeal disease are permitted.]
- •Previously untreated CNS disease. [Note: Previous or ongoing steroid treatment is permitted. Prophylaxis chemotherapy is not necessary, as induction chemotherapy will start within 72 hours after PTF-PET.]
- •At least one morphologically measurable lesion according to the IPCG criteria (Appendix 1).
- •Patients scheduled to undergo induction chemotherapy based on one of the following:
- •High-dose methotrexate (HD-MTX)-based chemotherapy, ICE/DeVIC or High-dose cytarabine (HD-AraC)-based chemotherapy.
- •ECOG performance status ≤ 2 for patients aged ≥65 years; ECOG performance status ≤ 3 for patients aged <65 years.
- •Life expectancy of at least 3 months, as estimated by the investigator.
- •For women of child-bearing potential: negative pregnancy test.
- •For sexually active female patients of child-bearing potential: The patient agrees to take adequate contraceptive measures during study participation and also agrees to continue use of this method for the duration of the study and for 6 months after the last dose of PTF.
- •For male patients whose partner is of child-bearing potential: The patient is willing to ensure that he and his partner use effective contraception during the study and for 6 months after the last dose of PTF.
排除标准
- •Known hypersensitivity to [68Ga]Ga-PentixaFor or its components.
- •Contraindication for contrast-enhanced MRI as set out in the relevant institutional guidelines (e.g., pacemaker, defibrillator, aneurysm clip, metal in the body, renal insufficiency, severe claustrophobia etc.).
- •Contraindication for the use of gadolinium contrast for MRI.
- •Contraindication for PET according to institutional guidelines (weight-based, e.g. weight > 180 kg).
- •Inability to lie still for the entire imaging time.
- •Systemic lymphoma manifestation (outside the CNS).
- •Presence of active infection at screening or history of serious infection within the previous 6 weeks (except HIV infection: patients with HIV-associated primary CNSL are considered eligible).
- •Administration of another investigational medicinal product within the 30 days (or 5 excretion half-lives, whichever period is the longer) before first treatment with PTF.
- •[Note: Re screening may be performed to accept washout of prior agents.]
- •Current toxicity of Grade >2 from previous standard or investigational therapies (grade according to the NCI Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE 5.0).
- •For female patients: Pregnancy (existing or intended) or breast-feeding.
- •Renal impairment: Both of the following:
- •Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2 Creatinine clearance < 60 ml/min
- •Hepatic impairment: Both of the following:
- •Aspartate aminotransferase (AST) > 3x upper limit of normal Alanine aminotransferase (ALT) > 3x upper limit of normal
- •Presence of any unstable systemic disease (including, but not limited to, active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease.
- •Presence of psychiatric disease, alcohol abuse or any other medical condition(s) that, in the opinion of the investigator, makes the patient unable to comply with study procedures and visits.
- •Patient weight ≤ 48 kg
研究组 & 干预措施
68Ga-PTF
Experimental
150 (+/-50) Megabecquerel (MBq) 68Ga-PTF will be injected intravenously at three timepoints during the course of the standard of care treatment.
干预措施: 68Ga-PTF (Drug)
结局指标
主要结局
Negative predictive value (NPV) of interim 68Ga-PTF-PET (after 6 ± 2 weeks of induction chemotherapy) for progression-free survival (PFS)
时间窗: after 6 +/-2 weeks of induction chemotherapy (interim examination) up to 12 months after induction chemotherapy completion (end of follow-up period)
68Ga-PTF PET negativity for CXCR4 will be determined by visual analysis in central reading. For PFS assessment (yes/no variable), tumour progression or relapse will be determined according to the IPCG response criteria (Abrey et al. 2005) for the time period starting at baseline and ending at approx. 12 months after induction chemotherapy completion. The negative predictive value is defined as follows: Number of patients without tumour progression or relapse / number of patients with interim 68Ga-PTF PET assessed as CXCR4-negative by central reviewer. The proportion obtained will be multiplied by 100 to obtain a percentage value. This NPV will be calculated for the entire study population and also stratified by induction chemotherapy regimen (HD-MTX-based, DeVIC/ICE, HD-AraC-based regimen).
次要结局
- Positive predictive value (PPV) of interim 68Ga-PTF PET (after 6 ± 2 weeks of induction chemotherapy) for PFS(after 6 +/-2 weeks of induction chemotherapy (interim examination) up to 12 months after induction chemotherapy completion (end of follow-up period))
- Frequency and severity of AEs(up to 6 months)
- Predictive values of 68Ga-PTF PET at the end of induction chemotherapy for PFS(end of induction chemotherapy up to 12 months after induction chemotherapy completion)
- Predictive values of 68Ga-PTF PET at interim examination (after 6 ± 2 weeks of induction chemotherapy) and end-of-chemotherapy-treatment for complete response (CR)(after 6 +/-2 weeks of induction chemotherapy (interim examination) up to 12 months after induction chemotherapy completion (end of follow-up period))
- Maximum standardized uptake value (SUVmax), SUVpeak and SUV mean(after 6 +/-2 weeks of induction chemotherapy (interim examination) up to 12 months after induction chemotherapy completion (end of follow-up period))
- Maximum tumour-to background ratio (TBRmax) and TBRmean(after 6 +/-2 weeks of induction chemotherapy (interim examination) up to 12 months after induction chemotherapy completion (end of follow-up period))
- Comparison of lesion numbers categorised as CNSL-suspect by 68Ga-PTF PET and MRI at baseline(after Visit 4 (after 6 +/-2 weeks of induction chemotherapy))
- Metabolic tumour volume (MTV)(after 6 +/-2 weeks of induction chemotherapy (interim examination) up to 12 months after induction chemotherapy completion (end of follow-up period))
- Predictive values of changes between pre-treatment and interim 68Ga-PTF PET imaging parameters for PFS(From visit 2 (first 68Ga-PTF PET) up to 12 months after induction chemotherapy completion)
- Sensitivity of pre-treatment 68Ga-PTF PET for CXCR4-positivity(up to 12 months after induction chemotherapy completion)
- Concordance in the classification as CNSL-suspect ('yes'/'no') by 68Ga-PTF PET and MRI at baseline, on a patient level(after Visit 4 (after 6 +/-2 weeks of induction chemotherapy))
- Observer agreement of 68Ga-PTF PET (inter- and intra-reader agreement)(through study completion, an average of 6 months)
研究者
研究点 (2)
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