EUCTR2015-003909-42-DE进行中（未招募）1 期
A Prospective, Open-Label, Multicenter, Phase 2 Trial to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib (GS-4059) and Idelalisib with and without Obinutuzumab in Subjects with Chronic Lymphocytic Leukemia
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
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) Documentation of relapsed or refractory CLL
- •2) Have an indication for treatment per modified IWCLL 2008 criteria; subjects without radiographically measureable disease (defined as = 1 lesion > 1.5cm in diameter as assessed by CT or MRI) must have bone marrow evaluation at screening
- •3) Adequate hematologic function as indicated by a platelet count = 50 x 10^9/L, a neutrophil count = 1 x 10^9/L and a hemoglobin = 8g/dL unless lower values are directly attributable to documented bone marrow burden of CLL
- •4) Adequate renal function as indicated by a CrCl = 50 mL/min calculated by the modified Cockroft-Gault formula or from a 24 hour urine collection
- •5) Adequate liver function as indicated by total bilirubin = 1.5x institutional upper limit of normal (ULN) unless attributed to Gilbert’s syndrome and AST/ALT = 2.5xULN
- •6) Male or female = 18 years of age
- •7) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 2
- •8) Absence of active HBV infection (serological testing within 6 weeks prior to randomization or enrollment with the following results: HBsAg negative AND anti-HBcAb negative, or if anti-HBcAb positive, HBV DNA PCR negative)
- •9) HCV Ab negative or if Ab positive, negative HCV RNA PCR within 6 weeks prior to randomization or enrollment
- •10) Negative testing for HIV within 6 weeks prior to randomization or enrollment
- •11) Satisfies the following criteria:
- •a) For female subjects of childbearing potential, willingness to abstain from sexual intercourse or use a protocol-specified method of contraception
- •b) Male subjects of reproductive potential who engage in sexual intercourse must agree to use protocol-specified method(s) of contraception
- •12) Ability and willingness to provide written informed consent and adhere to protocol requirements including study visit schedule, drug administration plan, imaging studies, laboratory testing, other study procedures and restrictions including mandatory prophylaxis for Pneumocystis jirovecii pneumonia (PJP)
- •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 11
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1) Known transformation of CLL (ie, Richter’s transformation, prolymphocytic leukemia)
- •2) Known CNS involvement
- •3) Progression on treatment with any inhibitor of BTK, SYK, PI3K, BCL-2 or obinutuzumab. The treatment and disease response history of subjects with prior treatment with agents in these classes should be reviewed by the sponsor or the GCLLSG study office prior to enrollment to clarify sensitivity to these treatments
- •4) Any treatment for CLL other than corticosteroids for symptomatic management within 28 days of the start of study treatment
- •5) Participation on a concurrent therapeutic clinical trial unless all treatment is complete with only ongoing surveillance
- •6) Diagnosis of or concern for progressive multifocal leukoencephalopathy
- •7) History of myelodysplastic syndrome or another malignancy other than CLL, except for the following: any malignancy that has been in complete remission for 3 years, adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for =1 year prior to start of study therapy.
- •8) Active infection requiring systemic therapy
- •9) Pregnant or nursing women (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment and monthly during therapy)
- •10) Active autoimmune disease including autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura requiring a higher corticosteroid equivalent than prednisone 10 mg daily. Higher doses of corticosteroids prescribed for any indication must be stopped >14 days prior to randomization or enrollment; exceptions may be made for corticosteroids prescribed
- •specifically for management of CLL symptoms after discussion with the study medical monitor.
- •11) Diagnosis of inflammatory bowel disease or ongoing symptomatic pneumonitis
- •12) Ongoing CMV infection, treatment or prophylaxis for CMV within the past 28 days
- •13) History of stroke or intracranial hemorrhage within 12 months of randomization or enrollment; subjects requiring therapeutic anticoagulation for any indication should be discussed with the GCLLSG coordinating physician and/or medical monitor prior to screening
- •14) Legal incapacity, prisoners or subjects institutionalized by regulatory or court order, or any individual in dependence to study sponsor or any investigator
- •15) Use of a strong CYP3A4 or a strong P-gp inducer within 2 weeks of first dose of study treatment or anticipated chronic use while on study
- •16) Demonstration of QTc interval > 450 milliseconds or requirement for ongoing treatment with concomitant medications that prolong the QT interval
- •17) Known hypersensitivity to obinutuzumab, idelalisib or tirabrutinib or any of the excipients
研究者
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