EUCTR2012-003968-44-CZ进行中（未招募）1 期
An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil) - RESONATE-2
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 272
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
- •1. Randomized in the parent study, PCYC-1115-CA
- •2. Informed consent for Study PCYC-1116-CA
- •3. IRC-confirmed PD in the parent study or closure of the parent study
- •To receive second-line ibrutinib, patients must meet all of the following criteria:
- •1. IRC-confirmed disease progression in the parent study (PCYC-1115-CA), or for patients who did not progress in the parent study, investigator-determined disease progression in the extension study (PCYC 1116-CA)
- •2. Received at least 3 cycles of chlorambucil therapy
- •3. Documented, protocol-defined reason for chlorambucil discontinuation:
- •No evidence of response in radiographically assessed disease parameters at Cycle 5 compared to baseline; no further response (defined as failure to reach at least a PR, or a plateau of response with no further improvement of disease parameters) after at least 6 cycles; could not tolerate treatment (a situation defined by the recurrence of toxicity of at least Grade 3 despite appropriate dose reductions and optimal symptomatic management); or maximum treatment of 12 cycles with chlorambucil
- •4. Demonstrates continuation of adequate organ function, performance status, and other criteria, as follows:
- •Eastern Cooperative Oncology Group (ECOG) status of 0-2
- •Adequate hematologic function, defined as absolute neutrophil count (ANC) = 0.75 x109/L (independent of growth factor support in the preceding 7 days) and platelet count = 30 x 109/L (independent of transfusion or growth factor support in the preceding 7 days)
- •Adequate hepatic function, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 x upper limit of normal (ULN), and total bilirubin = 1.5 xULN (unless due to Gilbert's syndrome)
- •Adequate renal function, defined as an estimated glomerular filtration rate = 30 mL/min using the Cockcroft-Gault equation
- •Patients must have recovered from acute toxicities due to prior chemotherapy, radiotherapy, investigational drugs or experimental treatments (non-hematologic toxicities have resolved to a NCI CTCAE [version 4.0] Grade of =2) prior to receiving next line ibrutinib on this study
- •5. Meets at least 1 of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for active disease requiring treatment (Hallek 2008):
- •Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin < 10 g/dL), and/or thrombocytopenia (platelets < 100,000/µL)
- •Massive (= 6 cm below the left costal margin), progressive, or symptomatic splenomegaly
- •Massive nodes (at least 10 cm longest diameter), progressive, or symptomatic lymphadenopathy
- •Progressive lymphocytosis with an increase of more than 50% over a 2 month period or a lymphocyte doubling time (LDT) of < 6 months. LDT may be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In patients with initial blood lymphocyte counts of < 30,000/µL, LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded.
- •Autoimmune hemolytic anemia and/or immune thrombocytopenia (see definitions below) that is poorly responsive to corticosteroids or other standard therapy
- •(Definitions: Autoimmune hemolytic anemia is defined by at least 1 marker of hemolysis [indirect bilirubin above th
排除标准
- •To receive second-line ibrutinib, patients must meet NONE of the following criteria:
- •1. Disease progression involving the central nervous system (CNS) or transformation to another histology
- •2. Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed
- •progressive disease
- •3. In the 4 weeks before dosing, radiation therapy, major surgery, or receipt of an investigational drug
- •4. Requirement for treatment with a strong CYP3A inhibitor
- •5. Uncontrolled systemic infection or requirement for intravenous (IV) antibiotics
- •6. Noncompliance on the parent study
研究者
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