A Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents

Gilead Sciences, Inc.0 sites125 target enrollmentFebruary 3, 2011

Overview

No summary available.

Registry

who.int

Start Date

February 3, 2011

End Date

May 16, 2018

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•Patients must meet all of the following conditions to be eligible for enrollment into the study:
•1\. Age \=18 years.
•2\. Karnofsky performance score of \=60 (Eastern Cooperative Oncology Group \[ECOG] performance score of 0, 1, or 2\).
•3\. Histologically confirmed diagnosis of B\-cell iNHL, with histological subtype limited to the following based on criteria established by the World Health Organization (WHO) 2008 classification of tumors of haematopoietic and lymphoid tissues:
•\- Follicular lymphoma (FL) Grade 1, 2, or 3a
•\- Small lymphocytic lymphoma (SLL) with absolute lymphocyte count \<5 x 10^9/L at the time of diagnosis and on baseline laboratory assessment performed within 4 weeks prior to the start of study drug administration
•\- Lymphoplasmacytoid lymphoma (LPL) with or without associated Waldenstroms Macroglobulinemia (WM)
•\- Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)
•4\. Histological materials documenting diagnosis of lymphoma available for review.
•5\. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of \=1 lesion that measures \>2 cm in the longest dimension \[LD] and \=1\.0 cm in the longest perpendicular dimension \[LPD] as assessed by CT or MRI)

•The presence of any of the following conditions will exclude a patient from study enrollment:
•1\. Central nervous system or leptomeningeal lymphoma.
•2\. Known histological transformation from iNHL to diffuse large B\-cell lymphoma.
•3\. History of a non\-lymphoma malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for \=5 years.
•4\. Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment (Visit 2\).
•5\. Pregnancy or breastfeeding.
•6\. Ongoing alcohol or drug addiction.
•7\. Known history of drug\-induced liver injury, chronic active HCV, chronic active HBV, alcoholic liver disease, non\-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension.
•8\. History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.
•9\. Ongoing immunosuppressive therapy, including systemic corticosteroids.