EUCTR2015-000366-66-ES进行中（未招募）1 期
Dose Optimization Study of Idelalisib in Follicular Lymphoma and Small Lymphocytic Lymphoma
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
- 240
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
入选标准
- •1. Male or female = 18 years of age
- •2. Histologically confirmed diagnosis of B-cell FL or SLL, with histological subtype limited to the following based on criteria established by the WHO 2008 classification of tumors of hematopoietic and lymphoid tissues:
- •a. FL Grade 1, 2, or 3a
- •b. SLL with absolute lymphocyte count < 5 x 10^9 /L at the time of diagnosis
- •3. Previous systemic treatment for FL or SLL
- •4. Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease per Lugano Classification
- •5. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of = 1 lesion that measures = 1.5 cm in the LD and = 1.0 cm in the LPD as assessed by PET CT, CT or MRI)
- •6. Has adequate performance status (such as ECOG Performance Status of = 2 or Karnofsky Performance Status of = 60)
- •7. Required baseline central laboratory data (within 4 weeks prior to start of study therapy) as shown in the table in the protocol.
- •8. For female subjects of childbearing potential, willingness to use a protocol recommended method of contraception during heterosexual intercourse from the signing of informed consent throughout the study treatment period and up to 30 days from the last dose of idelalisib (see Protocol)
- •9. For male subjects of reproductive potential having intercourse with females of childbearing potential, willing to use a protocol recommended method of contraception during heterosexual intercourse and to refrain from sperm donation throughout the study treatment period and for 90 days following discontinuation of idelalisib (see Protocol)
- •10. Lactating females must agree to discontinue nursing before study drug administration and at least 30 days following exposure
- •11. In the judgment of the investigator, participation in the protocol offers an acceptable benefit to risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject´s disease
- •12. Indicate willingness 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 indicating that the subject is aware of the neoplastic nature of their disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, possible side effects, potential risks and discomforts, and other pertinent aspects of study participation
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1. Known history of lymphoid malignancy other than FL or SLL
- •2. Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma
- •3. Known presence of intermediate- or high-grade myelodysplastic syndrome
- •4. Known history of serious allergic reaction including anaphylaxis or toxic epidermal necrolysis
- •5. History of a non-lymphoid malignancy except for the following: 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 enrollment, or any other cancer that has been in complete remission for = 5 years
- •6. Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
- •7. Known history of drug-induced liver injury, chronic active hepatitis B (HBV), chronic active hepatitis C (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
- •8. Ongoing drug-induced pneumonitis
- •9. Ongoing inflammatory bowel disease
- •10. Known human immunodeficiency virus (HIV) infection
- •11. Presence of any condition that could, in the opinion of the investigator, compromise the subject´s ability to participate in the study, such as history of substance abuse, alcoholism, or a psychiatric condition
- •12. History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
- •13. Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for autoimmune anemia and/or thrombocytopenia
- •14. Concurrent participation in another therapeutic clinical trial
- •15. 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
- •16. Prior treatment with idelalisib or other PI3K delta inhibitors, ibrutinib or other BTK inhibitors, mTOR inhibitors, or Syk inhibitors
研究者
相似试验
进行中（未招募）
1 期
A study to optimize the dose of Idelalisib in Follicular LymphomaFollicular LymphomaEUCTR2015-000366-66-CZGilead Sciences, Inc.266
进行中（未招募）
1 期
A study to optimize the dose of Idelalisib in Follicular LymphomaMedDRA version: 23.0Level: PTClassification code 10065856Term: Non-Hodgkin's lymphoma unspecified histology indolentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Follicular LymphomaEUCTR2015-000366-66-ITGILEAD SCIENCES INCORPORATED266
进行中（未招募）
1 期
A study to optimize the dose of Idelalisib in Follicular LymphomaFollicular LymphomaEUCTR2015-000366-66-GBGilead Sciences, Inc.266
终止
3 期
Dose Optimization Study of Idelalisib in Follicular LymphomaFollicular LymphomaNCT02536300Gilead Sciences96
进行中（未招募）
不适用
A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis. - DOSEModerate to severe plaque PsoriasisMedDRA version: 11.0Level: LLTClassification code 10037153Term: <Manually entered code. Term in E.1.1>EUCTR2008-000454-12-GRSchering Plough Research Institute, a Division of Schering Corporation200