NCT01292135已完成1 期
A Phase 1b, Multicenter, Open-label, Parallel-group Safety Study of a Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI 32765, in Combination With Chemotherapy in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Incidence of Prolonged Hematologic Toxicity Started in Cycle 1
研究概览
简要总结
The purpose of this study is to establish the safety of orally administered PCI-32765 in combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab (BR) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).
详细描述
This is a Phase 1b, open-label, parallel-group, nonrandomized, multicenter study of PCI 32765 420 mg once daily oral (PO) administration in combination with 2 different chemotherapy regimens in subjects with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed CLL or SLL and satisfying at least 1 of the following criteria for requiring treatment:
- •Progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies
- •Anemia (<11 g/dL) or thrombocytopenia (<100,000/μL) due to bone marrow involvement
- •Presence of unintentional weight loss > 10% over the preceding 6 months
- •NCI CTCAE Grade 2 or 3 fatigue
- •Fevers > 100.5° or night sweats for > 2 weeks without evidence of infection
- •Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of < 6 months
- •1 to 3 prior treatment regimens for CLL/SLL
- •ECOG performance status of ≤ 1
- •≥ 18 years of age
- •Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)
排除标准
- •Any chemotherapy, therapeutic antineoplastic antibodies (not including radio- or toxin immunoconjugates), radiation therapy, or experimental antineoplastic therapy within 4 weeks of first dose of study drug
- •Radio- or toxin-conjugated antibody therapy within 10 weeks of first dose of study drug
- •Concomitant use of medicines known to cause QT prolongation or torsades de pointes
- •Transformed lymphoma or Richter's transformation Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
- •Any of the following laboratory abnormalities: oAbsolute neutrophil count (ANC) < 1000 cells/mm3 (1.0 x 109/L) oPlatelet count < 50,000/mm3 (50 x 109/L) oSerum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN) oCreatinine > 2.0 x ULN or creatinine clearance < 40 mL/min
研究组 & 干预措施
PCI-32765 plus fludarabine/cyclophosphamide/rituximab (FCR)
Experimental
干预措施: PCI-32765 (Drug)
PCI-32765 plus bendamustine/rituximab (BR)
Experimental
干预措施: PCI-32765 (Drug)
结局指标
主要结局
Incidence of Prolonged Hematologic Toxicity Started in Cycle 1
时间窗: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.
次要结局
- Overall Incidence of Grade ≥3 Adverse Events (AEs) Per NCI CTCAE V4.0(From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.)
- Overall Incidence of Serious Adverse Events (SAEs)(From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.)
- Overall Response Rate (Complete Response [CR] + Complete Response With Incomplete Marrow Recovery [CRi] + Nodular Partial Response [nPR] + Partial Response [PR])(From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.)
- Incidence of Adverse Events Requiring Dose Delay or Discontinuation of Ibrutinib(From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.)
- Sustained Hematologic Improvement in Subjects With Neutropenia, Anemia, or Thrombocytopenia at Baseline(From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.)
- Progression Free Survival Rate at 12 Months(From first dose of any study medication to 12 months after first dose to progressive disease or death or the last clinical assessment before receiving new anticancer therapy or loss to follow-up, whichever occured the earliest.)
研究者
研究点 (6)
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