A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of IPI-145 in Combination with Rituximab vs Rituximab in Subjects with Previously-Treated Follicular Lymphoma

Infinity Pharmaceuticals, Inc0 个研究点目标入组 400 人开始时间: 2014年10月22日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•Diagnosis of CD20-positive FL:
•oHistology grades 1, 2 or 3a
•o Biopsy confirmed histopathological diagnosis of FL. Biopsy specimen should be obtained =2 years prior to randomization, unless medically contraindicated
•o CD20 immunophenotyping performed =2 years prior to randomization.
•First or subsequent relapse following at least one induction therapy regimen containing rituximab in combination with an anthracycline or rituximab in combination with an alkylating agent
•oPatients in first relapse must be chemoresistant or intolerant to chemotherapy
•No response or disease progression = 24 months from start of last previous therapy
•At least 1 measurable disease lesion >1.5 cm in at least one diameter by CT/CT-PET or magnetic resonance imaging (MRI) in an area of no prior radiation therapy, or in an area that was previously irradiated that has documented progression.
•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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•Clinical evidence of other indolent forms of lymphoma (e.g., marginal zone lymphoma [MZL], small lymphocytic lymphoma [SLL])
•Transformation to a more aggressive subtype of lymphoma or grade 3b FL
•Refractory to rituximab: defined as disease progression while receiving or within 6 months of completing either weekly rituximab induction therapy, or rituximab-based chemoimmunotherapy induction.
•Intolerance to rituximab or severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibodies
•Prior treatment with a PI3K inhibitor or BTK inhibitor

发起方

Infinity Pharmaceuticals, Inc