EUCTR2018-001923-38-ES进行中（未招募）1 期
Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia - ZUMA-8
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
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
- •101. Documentation of relapsed or refractory CLL AND a minimum of two prior treatment regimens with progression on treatment with ibrutinib
- •102. An indication for treatment per IWCLL 2018 criteria and radiographically measurable disease (at least 1 lesion > 1.5cm in diameter)
- •103. Adequate hematologic function
- •104. Adequate renal, hepatic, cardiac and pulmonary function
- •105. Age 18 or older
- •106. ECOG performance status of 0 or 1
- •107. Females of childbearing potential must have a negative serum or urine pregnancy test
- •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 78
排除标准
- •201. A history of treatment including any of the following:
- •a. Prior CD19 directed therapy
- •b. Treatment with alemtuzumab within 6 months before enrollment
- •c. Prior allogeneic hematopoietic stem cell transplant or donor lymphocyte infusion within 6 months prior to enrollment
- •d. Live vaccine administration within 4 weeks before enrollment
- •e. Systemic immunosuppression or systemic treatment for any autoimmune disease not related to CLL in the 2 years before enrollment
- •202. Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by IBMTR index
- •203. History of autoimmune disease resulting in end-organ injury unless attributable to CLL (eg, ITP, AIHA)
- •204. Diagnosis of Richter’s transformation or a history of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, skin, cervix, bladder, breast), superficial bladder cancer, asymptomatic localized low grade prostate cancer for which watch-and-wait approach is standard of care, or any other cancer that has been in remission for > 3 years prior to enrollment
- •205. History of severe hypersensitivity reaction attributed to aminoglycosides or any of the agents required for treatment in this study
- •206. CNS disease
- •207. History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome
- •208. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months before enrolment
- •209. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months before enrollment
- •210. Primary immunodeficiency
- •211. Known infection with HIV; chronic active hepatitis B; active hepatitis C. A history of hepatitis B or C is permitted if the viral load is undetectable by quantitative PCR or a comparable testing method.
- •212. Presence of active fungal, bacterial, viral infection or any infection requiring antimicrobial treatment for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite Medical
- •213. Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are permitted
- •217. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
研究者
相似试验
进行中（未招募）
1 期
A Phase 1/2 Multicenter Study of KTE-X19 in Adult Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia.Relapsed/Refractory Chronic Lymphocytic LeukemiaMedDRA version: 20.0Level: LLTClassification code 10008977Term: Chronic lymphocytic leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 20.1Level: LLTClassification code 10008978Term: Chronic lymphocytic leukemia refractorySystem Organ Class: 100000004864EUCTR2018-001923-38-DEKite Pharma, Inc16
进行中（未招募）
1 期
A Phase 1/2 Multicenter Study of KTE-X19 in Adult Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia.EUCTR2018-001923-38-ITKITE PHARMA INC.108
进行中（未招募）
1 期
A Phase 1/2 Multicenter Study of KTE-X19 in Adult Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia.Relapsed/Refractory Chronic Lymphocytic LeukemiaMedDRA version: 21.1Level: LLTClassification code 10008977Term: Chronic lymphocytic leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10008978Term: Chronic lymphocytic leukemia refractorySystem Organ Class: 100000004864EUCTR2018-001923-38-GBKite Pharma, Inc16
招募中
2 期
Study of KTE-X19 in Adult Japanese Subjects with Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic LeukemiaJPRN-jRCT2063230095Asou Hiroya21
进行中（未招募）
2 期
A multi center, phase 2 study to Evaluate safety and efficacy of total Neoadjuvant treatment of long courSE radiotherapy followed by cheMotherapy, capecitaBine combined with oxaliplatin (CAPOX) for Locally advanced rEctal cancer(ENSEMBLE-2)JPRN-jRCTs071210143KAGAWA Yoshinori27