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

Asou Hiroya0 个研究点目标入组 230 人开始时间: 2024年1月31日最近更新: 2024年5月27日

试验速览

暂无简介。

•1. Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
•2. Relapsed/refractory disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after > =2 prior systemic lines of therapy
•3. Clinical indication for treatment.
•4. At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
•5. Adequate renal, hepatic, pulmonary, and cardiac function

•- Presence of large B cell lymphoma or transformed FL
•- Small lymphocytic lymphoma
•- Lymphoplasmacytic lymphoma
•- Full-thickness involvement of the gastric wall by lymphoma
•- FL Grade 3b
•- Prior CD19-targeted therapy
•- Prior CAR therapy or other genetically modified T-cell therapy
•- Uncontrolled fungal, bacterial, viral, or other infection
•- Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus
•- History or presence of a clincially significant central nervous system (CNS) disorder.
•- History of autoimmune disease
•- Known history or CNS lymphoma involvement
•- Cardiac lymphoma involvement
•- History of clinically significant cardiac disease 6 months before randomization
•- Neuropathy Grade 1 or 2
•- Females who are pregnant or breastfeeding
•- Individuals of both genders who are not willing to practice birth control
•- Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardial catheter, or Ommaya reservoirs). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.

发起方

Asou Hiroya