NL-OMON51764撤回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 - Diagnostic imaging in CNS lymphoma patients.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •All study patients must meet all the following criteria:
- •1.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.]
- •2.Patient aged 18 years or above (either sex).
- •3.Histologically confirmed primary or secondary CNSL based on cytology/flow
- •cytometry of cerebrospinal fluid (CSF) or brain biopsy.
- •4.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.
- •5.At least one measurable parenchymal lesion. [Note: parenchymal CNSL is a
- •*must*, and additional locations such as leptomeningeal disease are permitted.]
- •6.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.]
- •7.At least one morphologically measurable lesion according to the IPCG criteria
- •(Appendix 1).
- •8.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.
- •9.ECOG performance status <= 2 for patients aged >=65 years;ECOG performance
- •status <= 3 for patients aged <65 years.
- •10.Life expectancy of at least 3 months, as estimated by the investigator.
- •11.For women of child-bearing potential: negative pregnancy test.
- •12.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.
- •13.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
- •Any patient meeting one or more of the following criteria will not be included:
- •1.Known hypersensitivity to [68Ga]Ga-PentixaFor or its components.
- •2.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.).
- •3.Contraindication for the use of gadolinium contrast for MRI.
- •4.Contraindication for PET according to institutional guidelines (weight-based,
- •e.g. weight > 180 kg).
- •5.Inability to lie still for the entire imaging time.
- •6.Systemic lymphoma manifestation (outside the CNS).
- •7.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).
- •8.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.]
- •9.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).
- •10.For female patients: Pregnancy (existing or intended) or breast-feeding.
- •11.Renal impairment: Both of the following: Estimated glomerular filtration
- •rate (eGFR) < 30 ml/min/1.73 m2 Creatinine clearance < 60 ml/min
- •12.Hepatic impairment: Both of the following: Aspartate aminotransferase (AST)
- •> 3 upper limit of normalAlanine aminotransferase (ALT) > 3 upper limit
- •13.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.
- •14.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.
- •15. Patient weight <= 48 kg
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