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
The purpose of this study is to evaluate the efficacy and safety of idelalisib in patients with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. The primary objective will be to assess the overall response rate. Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant patients as long as the study is still ongoing and the patients appear to be benefiting from treatment with acceptable safety.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Idelalisib
Phase: Phase 2
Ages Eligible For Study:
- Age ? 18 years - Karnofsky performance score of ? 60 (Eastern Cooperative Oncology Group [ECOG] performance score of 0, 1, or 2) - Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following: - Follicular lymphoma (FL) - Small lymphocytic lymphoma (SLL) with absolute lymphocyte count - Lymphoplasmacytic lymphoma (LPL), with or without associated Waldenstroms Macroglobulinemia (WM) - Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal) - Prior treatment with ? 2 prior chemotherapy-based or immunotherapy-based regimens for iNHL - Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy - Prior treatment with rituximab and with an alkylating agent (eg, bendamustine, cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for iNHL - Lymphoma that is refractory to rituximab and to an alkylating agent - Discontinuation of all other therapies for treatment of iNHL ? 3 weeks before Visit 2 - For men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods - Willingness and ability to provide written informed consent and to comply with the protocol requirements