Conditions: Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Diffuse Large B-cell Lymphoma Indolent Non-Hodgkin's Lymphoma
Keywords: GS-US-339-0103 SYK inhibitor PI3K inhibitor GS-9973 GS 9973 GS-1101 GS 1101 Cal-101 Cal 101 idelalisib leukemia lymphoma CLL MCL DLBCL iNHL FL MZL LPL SLL WM Waldenström's macroglobulinemia
Allocation:  | Intervention model: SEQUENTIAL
Enrollment: 66
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy of the combination entospletinib and idelalisib in participants with relapsed or refractory hematologic malignancies. Participants will be enrolled who have one of the following hematological tumor types: chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), or indolent non-Hodgkin lymphomas (iNHL; including follicular lymphoma (FL) and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia \[LPL/WM\], small lymphocytic lymphoma \[SLL\], or marginal zone lymphoma \[MZL\]).

Detailed description:

Arms:
arm 1: Entospletinib plus idelalisib at one of 4 dose combinations (400 mg/100 mg; 600 mg/100 mg; 800 mg/100 mg; 800 mg/150 mg).

After discontinuation of entospletinib+idelalisib combination therapy, and following a washout period, participants may continue to receive entospletinib 400 mg monotherapy.

Interventions: intervention 1: Entospletinib intervention 2: Idelalisib
Intervention descriptions: intervention 1: Entospletinib tablets administered orally twice daily intervention 2: Idelalisib tablets administered orally twice daily

Protocol document: