NL-OMON54144招募中2 期
A phase II non-inferiority study comparing point-of-care produced CAR T-cell to commercial CAR T-cells in patients with relapsed/refractory Non-Hodgkin Lymphoma - HOVON 161 CAR T
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
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
- •Histologically confirmed DLBCL and associated subtypes, defined by WHO 2016
- •classification: DLBCL not otherwise specified (NOS), High-grade B-cell lymphoma
- •with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) and
- •FL3B, T-cell/histocyte rich B-cell lymphoma, Primary mediastinal B-cell
- •lymphoma, EBV+ DLBCL, transformed lymphoma (transformed follicular) and R/R
- •after at least 2 lines of systemic therapy
- •Age >= 18 years
- •ECOG/WHO performance status >2
- •Secondary central nervous system (CNS) involvement is allowed however, then
- •he/she must have
- •- No signs or symptoms of CNS involvement that would hamper adequate ICANS
- •Estimated life expectancy of >3 months other than primary disease
- •Patients of child-bearing or child-fathering potential must be willing to
- •practice birth control from the time of enrollment on this study and for four
- •months after receiving the preparative regimen
- •Signed and dated informed consent before conduct of any trial-specific
- •Patient is capable of giving informed consent
排除标准
- •Absolute neutrophil count (ANC) <1.0x109/L
- •Platelet count <50x109/L
- •Absolute lymphocyte count <0.1x109/L
- •Primary CNS lymphoma
- •Known history of infection with hepatitis C or B virus unless treated and
- •confirmed to be PCR negative
- •Active HIV infection with detectable viral load or CD4 T-cell count below
- •0.20x109/L
- •Known history or presence of seizure activities or on active anti- seizure
- •medications within the previous 12 months
- •Known history of CVA within prior 12 months
- •Unstable neurological deficits
- •Known history or presence of autoimmune CNS disease, such as multiple
- •sclerosis, optic neuritis or other immunologic or inflammatory disease
- •Active systemic autoimmune disease for which immunnosupressive therapy is
- •Presence of CNS disease that, in the judgment of the investigator, may impair
- •the ability to evaluate neurotoxicity, baseline dementia that would interfere
- •with therapy or monitoring, determined using mini-mental status exam at baseline
- •Active systemic fungal, viral or bacterial infection
- •Clinical heart failure with NYHA class >=2 or LVEF <40%
- •Resting oxygen saturation <92% on room air
- •Liver dysfunction as indicated by total bilirubin, AST and/or ALT >5 x
- •institutional ULN, unless directly attributable to the lymphoma or Gilbert
- •GFR <40 mL/min calculated according to the modified formula of Cockcroft and
- •Gault or by direct urine collection
- •Pregnant or breast-feeding woman
- •Active other malignancy requiring treatment
- •Medical condition requiring prolonged use of systemic immunosuppressives with
- •exception of prednisolon<10 mg/day
- •History of severe immediate hypersensitivity reaction against any drug or its
- •Ingredients/ impurities that is scheduled to be given during trial
- •participation e.g. as part of the mandatory lymphodepletion protocol,
- •premedication for infusion, or rescue medication/salvage therapies for
- •treatment related toxicities
- •Any psychological, familial, sociological and geographical condition
- •potentially hampering compliance with the study protocol and follow-up schedule
研究者
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