EUCTR2015-005009-35-FR进行中（未招募）1 期
A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3) - ZUMA-3
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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. Relapsed or refractory B-precursor ALL defined as one of the following:
- •- Primary refractory disease
- •- First relapse if first remission = 12 months
- •- Relapsed or refractory disease after first or later salvage therapy
- •- Relapsed or refractory disease after allogeneic transplant provided subject is at least 100 days from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment
- •102. Morphological disease in the bone marrow (= 5% blasts)
- •103. Subjects with Ph+ disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs
- •104. Age 18 or older
- •105. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- •106. ANC = 500/uL unless in the opinion of the PI cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy
- •107. Platelet count = 50,000/uL unless in the opinion of the PI cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy
- •108. Absolute lymphocyte count = 200/µL
- •109. Adequate renal, hepatic, pulmonary and cardiac function defined as:
- •- Creatinine clearance (as estimated by Cockcroft Gault) = 60 cc/min
- •- Serum ALT/AST = 2.5 x ULN
- •- Total bilirubin = 1.5 mg/dl, except in subjects with Gilbert’s syndrome.
- •- Cardiac ejection fraction = 50%, no evidence of pericardial effusion as determined by an ECHO, no NYHA class III or class IV functional classification, and no clinically significant arrhythmias
- •- No clinically significant pleural effusion
- •- Baseline oxygen saturation > 92% on room air
- •110. Females of childbearing potential must have a negative serum or urine pregnancy test
- •111. In subjects previously treated with blinatumomab, CD19 tumor expression in bone marrow or peripheral blood must be documented after completion of the most recent prior line of therapy. If CD19 expression is quantified, then there must be = 90% CD19 positive blasts.
- •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 75
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •201. Diagnosis of Burkitt’s leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
- •202. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
- •203. Isolated extramedullary disease
- •204. CNS abnormalities
- •a. Presence of CNS-3 disease, defined as detectable cerebrospinal blast cells in a sample of CSF with = 5 WBCs per mm3 with or without neurological changes, and presence of CNS-2 disease defined as detectable cerebrospinal blast cells in a sample of CSF with <5 WBCs per mm3 with neurological changes. Note: Subjects with CNS-1 (no detectable leukemia in the CSF) and those with CNS-2 without clinically evident neurological changes are eligible to participate in the study.
- •b. History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
- •205. History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome.
- •206. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
- •207. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment
- •208. Primary immunodeficiency
- •209. Known infection with HIV, hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of treated hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
- •210. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor
- •211. Prior medication:
- •- Salvage chemotherapy including TKIs for Ph+ ALL within 1 week prior to enrollment
- •- Prior CD19 directed therapy other than blinatumomab
- •- Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
- •- Donor lymphocyte infusion (DLI) within 28 days prior to enrollment
- •- Any drug used for GVHD within 4 weeks prior to enrollment (e.g. calcineurin inhibitors, methotrexate, mycophenolyate, rapamycin, thalidomide, or immunosuppressive antibodies such as rituximab, anti-tumor necrosis factor, anti-interleukin 6 or anti-interleukin 6 receptor)
- •- At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy prior to enrollment (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists etc)
- •- Corticosteroid therapy at a pharmacologic dose (> 5 mg/day of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided for 7 days prior to enrollment
- •212. Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted
- •213. Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by IBMTR index; acute or
研究者
相似试验
进行中（未招募）
1 期
A Study Evaluating the Safety and Effectiveness of KTE-X19 in Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia.EUCTR2015-005009-35-NLKite Pharma, Inc.100
进行中（未招募）
1 期
A Study Evaluating the Safety and Effectiveness of KTE-X19 in Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia.Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL)MedDRA version: 21.0Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 100000004864EUCTR2015-005009-35-DEKite Pharma Inc.100
进行中（未招募）
1 期
A Study Evaluating the Safety and Efficacy of KTE-X19 in pediatric and adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory Non-Hodgkin LymphomaRelapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) Relapsed/Refractory B-cell non-Hodgkin lymphoma (r/r NHL)MedDRA version: 21.0Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10006595Term: Burkitt's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10036710Term: Primary mediastinal large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-005010-30-BEKite Pharma, Inc.116
进行中（未招募）
1 期
A Study Evaluating the Safety and Effectiveness of KTE C19 in Subjects with Aggressive Non-Hodgkin Lymphoma (NHL) resistant to other treatments.EUCTR2015-005007-86-FRKite Pharma Inc.166
进行中（未招募）
1 期
A Study Evaluating the Safety and Efficacy of KTE-C19 in pediatric and adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic LeukemiaRelapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL)MedDRA version: 20.0Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 100000012958EUCTR2015-005010-30-FRKite Pharma Inc.75