NCT00496132终止1 期
An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Who Have Been Treated With a Purine Nucleoside Analogue-Containing Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 主要终点
- Dose-limiting toxicities and adverse events
研究概览
简要总结
This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with chronic lymphocytic leukemia (CLL) who have relapsed after or were refractory to treatment with a purine nucleoside analogue-containing regimen. The trial will enroll in two phases: a Phase I dose-escalation portion and a Phase II expanded treatment cohort, with enrollment of additional patients in order to expand safety experience and collect preliminary anti-leukemia activity data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented history of histologically confirmed B-cell CLL
- •Relapsed or refractory CLL with history of prior treatment with purine nucleoside analogue-containing regimen
- •Eligible for treatment of their CLL based on criteria adapted from the National Cancer Institute-Working Group (NCI-WG) Response Criteria for CLL
- •For patients of reproductive potential (males and females), use of a reliable means of contraception
- •For females of childbearing potential, a negative serum pregnancy test
排除标准
- •Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab)
- •Prior use of any non-CD20 targeted monoclonal antibody therapy within 6 months of enrollment
- •Current or recent CLL treatment
- •History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
- •Evidence of acute/active autoimmune hemolytic anemia or other autoimmune complications of CLL
- •Use of hematopoietic growth factors or RBC and/or platelet transfusions
- •Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
- •Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination
- •History of cancer other than CLL)
- •Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics
- •A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening
- •Positive hepatitis B or C serology
- •Positive human immunodeficiency virus (HIV) serology
- •Active cytomegalovirus (CMV) disease by antigen or polymerase chain reaction testing
- •Pregnancy or lactation
- •CNS leukemia
- •Recent major surgery, other than diagnostic surgery
研究组 & 干预措施
1
Experimental
干预措施: PRO131921 (Drug)
结局指标
主要结局
Dose-limiting toxicities and adverse events
时间窗: Length of study
次要结局
- Pharmacokinetic parameters; CD19-positive B-cell counts(Length of study)
- Overall response rate and progression-free survival (Phase II only)(Length of study)
研究者
相似试验
终止
1 期
A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's LymphomaNon-Hodgkin's LymphomaNCT00452127Genentech, Inc.26
招募中
1 期
A Study of CM350 in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT05263960Keymed Biosciences Co.Ltd248
终止
1 期
Study of ET140202 T Cells in Adults With Advanced Hepatocellular CarcinomaLiver NeoplasmHepatocellular CarcinomaMetastatic Liver CancerLiver CancerNCT03998033Eureka Therapeutics Inc.2
招募中
1 期
T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)Refractory B-Cell Non-Hodgkin LymphomaB-Cell Non-Hodgkin's Lymphoma (NHL)Lymphoma, Non-HodgkinsLymphomas Non-Hodgkin's B-CellNon-Hodgkin LymphomaNon-Hodgkin's LymphomaLarge B-Cell LymphomaLymphoma, Non-Hodgkin's, AdultRefractory Non-Hodgkin LymphomaRelapsed Non-Hodgkin LymphomaLymphoma, Non-HodgkinHIV Associated LymphomaLymphomaCNS LymphomaHigh-grade B-cell LymphomaNCT06343311Estrella Biopharma, Inc.21
终止
1 期
A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast CancerSolid CancersNon-Hodgkin's LymphomaNCT01296555Genentech, Inc.674