EUCTR2015-004033-28-HU进行中（未招募）1 期
A Phase 3, Randomized, Double-blind Study of Duvelisib Administered in Combination with Rituximab and Bendamustine vs Placebo Administered in Combination with Rituximab and Bendamustine in Subjects with Previously-Treated Indolent Non-Hodgkin 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
- 600
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
- •= 18 years of age
- •Diagnosis of iNHL with one of the following histologic sub-types and grade:
- •- Follicular lymphoma (FL)Grade 1, 2, or 3a
- •- Small lymphocytic lymphoma (SLL)
- •- Marginal zone lymphoma (MZL)( splenic, nodal, or extranodal)
- •Have received the following systemic treatments for iNHL:
- •- an anti-CD20 antibody; and
- •- chemotherapy
- •At least 1 measurable disease lesion > 1.5 cm in at least one dimension by computed tomography (CT)/CT-PET or magnetic resonance imaging (MRI)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (corresponds to Karnofsky Performance Status [(KPS) =60%])
- •For full inclusion criteria list, refer to protocol.
- •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 420
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B FL
- •Refractory to BR, defined as:
- •- Progression of disease while receiving or within 6 months of completing bendamustine + rituximab therapy
- •Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
- •Received prior allogeneic transplant
- •Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
- •Infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- •History of tuberculosis treatment within the two years prior to randomization
- •History of chronic liver disease, veno-occlusive disease, or alcohol abuse
- •Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) daily (QD)
- •Ongoing treatment for systemic bacterial, fungal, or viral infection at screening
- •Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
- •Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia
- •History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to screening
- •For full exclusion criteria list, refer to protocol.
研究者
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