EUCTR2013-003314-41-PT进行中（未招募）1 期
A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia with 17p Deletion
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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) Male or female =18 years of age.
- •2) Documented diagnosis of B-cell CLL, according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008.
- •3) Presence of 17p deletion in CLL cells as demonstrated by FISH testing performed at a central laboratory.
- •4) No prior therapy for CLL other than corticosteroids for disease complications.
- •5) CLL that warrants treatment based on pre-defined criteria.
- •6) Presence of measurable lymphadenopathy confirmed by the Independent Review Committee (IRC) (defined as the presence of =1 nodal lesion that measures =2.0 cm in the longest dimension [LD] and =1.0 cm in the longest perpendicular dimension [LPD] as assessed by computed tomography [CT] or magnetic resonance imaging [MRI]).
- •7) ECOG performance status of =2.
- •8) Required baseline laboratory data (within 28 days prior to enrollment) as shown in the protocol.
- •9) For female subjects of childbearing potential, willing to use a protocol-recommended method of contraception from the signing of informed consent throughout the study treatment period and 30 days from the last dose of IDELA or 12 months from the last dose of rituximab, whichever is later.
- •10) Male subjects of reproductive potential having intercourse with females of childbearing potential, must agree to utilize protocol specified methods of contraception and refrain from sperm donation from the enrollment visit throughout the study treatment period and up to 3 months from the last dose of IDELA or 12 months from the last dose of rituximab, whichever is later.
- •11) Lactating females must agree to discontinue nursing before study drug administration.
- •12) Willing and able to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions.
- •13) Evidence of a signed informed consent.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1) Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation).
- •2) Known presence of myelodysplastic syndrome.
- •3) History of a non-CLL malignancy with the following exceptions:
- •a) the malignancy has been in remission without treatment for =5 years prior to enrollment, or
- •b) carcinoma in situ of the cervix, or
- •c) adequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, or
- •d) asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for =1 year prior to enrollment, or
- •e) DCIS of the breast treated with lumpectomy alone, or
- •f) Other adequately treated Stage 1 or 2 cancer currently in complete remission.
- •4) Known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for IDELA, or rituximab
- •5) Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment.
- •6) Ongoing drug-induced liver injury, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
- •7) History of non-infectious pneumonitis.
- •8) Ongoing inflammatory bowel disease.
- •9) History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.
- •10) Ongoing immunosuppressive therapy other than corticosteroids.
- •11) Received last dose of study drug on another therapeutic clinical trial within 30 days prior to enrollment.
- •12) Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality that, in the investigator’s opinion, could adversely affect the safety of the subject or impair the assessment of study results.
- •13) Subject has undergone major surgery other than diagnosis surgery within 30 days prior to enrollment.
研究者
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