Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

PHASE1CompletedINTERVENTIONAL
Enrollment

241

Participants

Timeline

Start Date

March 25, 2010

Primary Completion Date

April 28, 2015

Study Completion Date

April 28, 2015

Conditions
Indolent Non-Hodgkin's LymphomaChronic Lymphocytic LeukemiaMantle Cell Lymphoma
Interventions
DRUG

Idelalisib

Idelalisib tablet administered orally

DRUG

Rituximab

Rituximab administered intravenously

DRUG

Bendamustine

Bendamustine administered intravenously

DRUG

Ofatumumab

Ofatumumab administered intravenously

DRUG

Fludarabine

Fludarabine administered orally

DRUG

Everolimus

Everolimus administered orally twice daily until disease progression

DRUG

Bortezomib

Bortezomib administered as a subcutaneous injection

DRUG

Chlorambucil

Chlorambucil administered on Days 1-7 every 28 days to allow appropriate therapy for participants with CLL and to coordinate into a cycle period equivalent to other study treatment regimens.

DRUG

Lenalidomide

Lenalidomide administered orally

Trial Locations (11)

10021

Weill Medical College of Cornell, New York

11040

Long Island Jewish Medical Center, New Hyde Park

20817

Center for Cancer and Blood Disorders, Bethesda

35805

Clearview Cancer Institute, Huntsville

37203

Sarah Cannon Research Institute, Nashville

63110

Washington University School of Medicine, St Louis

77030

MD Anderson Cancer, Houston

90024

UCLA, Los Angeles

97477

Willamette Valley Cancer Institute and Research Center, Springfield

98902

North Star Lodge Cancer Center, Yakima

94304-5548

Stanford Cancer Center, Palo Alto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY