EUCTR2017-004628-31-IT进行中（未招募）1 期
Rituximab, bendamustine and cytarabine followed by venetoclax (V-RBAC) in high-risk elderly patients with mantle cell lymphoma (MCL)
Fondazione Italiana Linfomi ONLUS0 个研究点目标入组 130 人开始时间: 2018年3月19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
- 130
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
入选标准
- •1.Previously untreated patients with MCL aged =65 years if they are FIT according to the geriatric CGA assessment.
- •2.age =64 years not eliglible to high-dose chemotherapy plus transplantation, FIT or UNFIT according to the geriatric CGA assessment.
- •3.Measurable nodal or extranodal disease = 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions.
- •4.ECOG performance status =2.
- •5.Positivity for cyclin D1 and/or SOX11 [the latter being mandatory in cases lacking cyclin D1- or t(11;14)-negative].
- •6.Adequate renal function (Creatinine clearance >50 mL/min), with preserved diuresis.
- •7.Adequate liver function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <2.5 x upper limit of normal (ULN) value, total bilirubin <1.5 x ULN, unless directly attributable to the patient’s tumor or to congenital causes.
- •8.Hepatitis B core antibody (HBcAb) positive/HBsAg negative/HBV-DNA negative patients may be enrolled if correct antiviral prophylaxis is administered at least 2 weeks before initiating protocol treatment.
- •9.Written informed consent.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1.Human immunodeficiency virus (HIV) positive.
- •2.Previous treatment for lymphoma.
- •3.Disease confined to the bone marrow/peripheral blood/spleen, without any other nodal or extranodal involvement.
- •4.In-situ MCL.
- •5.Medical conditions or organ injuries that could interfere with administration of therapy.
- •6.Active bacterial, viral, or fungal infection requiring systemic therapy.
- •7.Seizure disorders requiring anticonvulsant therapy.
- •8.Severe chronic obstructive pulmonary disease with hypoxiemia.
- •9.History of severe cardiac disease: New York Heart Association (NYHA) functional class III-IV, myocardial infarction within 6 months, ventricular tachyarrhythmias, dilatative cardiomyopathy, or unstable angina.
- •10.Uncontrolled diabetes mellitus.
- •11.Active secondary malignancy.
- •12.Known hypersensitivity or anaphylactic reactions to murine antibodies and proteins, to Bendamustine or mannitol.
- •13.Major surgery within 4 weeks of study Day 1.
- •14.HBsAg+
- •15.HCVAb+ patients with active viral replication (HCV-RNA+ with AST>2 x normal limit)
- •16.Any co-existing medical or psychological condition that would preclude participation in the study or compromise the patient’s ability to give informed consent, or that may affect the interpretation of the results, or render the patient at high risk from treatment complications.
- •17.CNS involvement
- •18.Chronic treatment with strong or moderate CYP3A inhibitors (e.g. ketoconazole, ritonavir, clarithromycin, itraconazole, voriconazole)
研究者
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