EUCTR2021-003260-28-ES进行中（未招募）1 期
A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma - ZUMA-22
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
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
- 性别
- All
入选标准
- •1) Histologically-confirmed FL (Grade 1, 2, or 3a) per local diagnosis. If clinically permissible, a new biopsy is strongly recommended at screening to exclude subjects with transformed disease or those who were initially misdiagnosed. Tumor tissue must be provided for retrospective central pathology review. If an archival specimen is not available, a new biopsy is required prior to randomization.
- •2) R/r disease as defined as one of the following options:
- •a) First-line systemic chemoimmunotherapy and high-risk disease, defined as relapse or progression within 24 months of initiation of the initial course of chemoimmunotherapy
- •i) The initial chemoimmunotherapy regimen must consist of an anti-CD20 monoclonal antibody plus either B, CHOP, or CVP. The subject must have received at least 3 cycles of the anti-CD20 monoclonal antibody plus either B, CHOP, or CVP regimen. In the case of the anti-20 monoclonal antibody plus CHOP regimen, the CHOP regimen may have included a prednisone-equivalent dose of any corticosteroid.
- •ii) Progression is measured from the first day of the first cycle of the initial chemoimmunotherapy.
- •iii) Note: Subjects who received frontline anti-CD20 monoclonal antibody monotherapy prior to the initial line of chemoimmunotherapy are eligible. However, progression within 24 months will be counted from C1D1 of the chemoimmunotherapy regimen and not from the start of the frontline anti-CD20 monoclonal antibody monotherapy that precedes the chemoimmunotherapy.
- •b) R/r disease after = 2 prior systemic lines of therapy where:
- •i) Relapsed disease is defined as subjects who progressed more than 6 months from completion of prior systemic therapy
- •ii) Refractory disease is defined as subjects who experienced lack of response to treatment or have experienced PD within 6 months of prior systemic therapy completion
- •iii) Note: (1) Involved field/site radiation, maintenance, and consolidation therapies are not considered separate lines of therapy for purposes of eligibility. Single-agent anti-CD20 will not be considered a separate line of therapy for purposes of eligibility.
- •(2) Prior therapy must have included an anti-CD20 monoclonal antibody combined with an alkylating agent.
- •3) Clinical indication for treatment, including but not limited to local symptoms due to progressive or bulky disease, systemic B symptoms, compromised organ function due to disease progression, cytopenias due to marrow involvement, or symptomatic extranodal disease.
- •4) At least 1 measurable lesion per the Lugano Classification on anatomical imaging such as CT imaging. Previously irradiated lesions are considered measurable only if progression was documented following completion of radiation therapy.
- •5) No known history or suspicion of CNS lymphoma involvement
- •6) Elapsed time of at least 2 weeks or 5 half-lives, whichever was shorter, since any prior systemic therapy and randomization, except for systemic inhibitory/stimulatory immune checkpoint therapy. Elapsed time of at least 3 half-lives since any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy and randomization.
- •7) Toxicities due to prior therapy must have been stable and recovered to Grade 1 or lower (except for clinically nonsignificant toxicities, such as alopecia)
- •8) Age 18 or older
- •9) ECOG Performance Status of 0 or 1
- •10) Absolute neutrophil count = 1000/µL
- •11) Platelet count = 75,000/µL unless secondary to bone marrow or spleen involvement by lymphoma where platelet count =
排除标准
- •1) History of large B cell lymphoma or history of transformed FL at the time during the subject´s lifetime including at the time of screening.
- •2) FL Grade 3b
- •3) Small lymphocytic lymphoma
- •4) Lymphoplasmacytic lymphoma
- •5) Full-thickness involvement o the gastric wall by lymphoma
- •6) History of malignancy other than nonmelanoma skin cancer or carcinoma in situ unless disease-free and without anticancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years. Subjects with asymptomatic localized low-grade prostate cancer, for which a watch-and-wait approach is SOCT, are eligible.
- •7) Intention for subject to proceed to auto-SCT or allogeneic SCT
- •8) History of allogenic SCT except if no donor cells are detected on chimerism, the subject is off all immunosuppression, and there is no evidence of active GVHD of any grade
- •9) Auto-SCT within 6 weeks of the planned axicabtagene ciloleucel infusion
- •10) Prior CD19-targeted therapy
- •11) Prior CAR therapy or other genetically modified T-cell therapy
- •12) History of severe, immediate hypersensitivity reaction attributed to aminoglycosides.
- •13) Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if the subject is responding to active treatment and satisfies the criteria of being afebrile (ie. temperature <38ºC) for at least 24 hours prior to the investigator confirming the subject´s eligibility.
- •14) Infection with human immunodeficiency virus, hepatitis B virus , or hepatitis C virus . If there is a positive history of HBV or hepatitis C virus, the viral load must be undetectable per quantitative polymerase chain reaction and/or nucleic acid testing.
- •15) History or presence of a CNS disorder, such as hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome, or cerebral edema with confirmed structural defects by appropriate imaging. History of stroke or transient ischemic attack within 12 months before randomization, or seizure disorders requiring active anticonvulsive medication.
- •16) History of autoimmune disease (eg, Crohn’s, rheumatoid arthritis, or systemic lupus) resulting in or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 2 years.
- •17) Detectable cerebrospinal fluid (CSF) malignant cells or brain metastases or a history of CNS lymphoma, primary CNS lymphoma, or spinal epidural involvement.
- •18) Cardiac atrial or cardiac ventricular lymphoma involvement
- •19) History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of randomization
- •20) History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, or Shwachman-Diamond syndrome
- •21) History of non-line associated, clinically significant (CTCAE 5.0 Grade 2) deep-vein thrombosis (ie, proximal deep vein thrombosis) or pulmonary embolism requiring therapeutic anticoagulation within the 3 months before randomization
- •22) Any medical condition likely to interfere with assessment of safety or efficacy study treatment
- •23) History of severe hypersensitivity reaction to any of the agents used in this study
- •24) Live vaccine = 6 weeks of randomization and/or anticipation of need for such a
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