Study of BKM120 & Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

July 21, 2014

Primary Completion Date

September 12, 2018

Study Completion Date

April 9, 2019

Conditions
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueNodal Marginal Zone B-cell LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaSplenic Marginal Zone LymphomaWaldenström Macroglobulinemia
Interventions
DRUG

PI3K inhibitor BKM120

Will be supplied to each patient on the first day of each cycle. It will subsequently be self administered by the patient themselves daily on days 1-28 of every 28 day cycle

BIOLOGICAL

rituximab

Given IV (intervenously) on days 2, 8, 15, and 22 of cycle 1, and subsequently on day 1 of cycles 3, 5, 7, 9, and 11.

OTHER

Pharmacodynamics

Pharmacodynamic samples from peripheral blood (for those with peripheral blood involvement) and bone marrow aspirate (for all patients) are drawn at baseline.

OTHER

Correlative studies

Patients will undergo correlative studies to include bone marrow biopsy at study enrollment, and at the time of complete remission. In addition, patients with peripheral blood involvement at enrollment will have peripheral blood drawn for all planned research correlates.

Trial Locations (2)

30322

Emory University, Atlanta

43210

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Kami Maddocks, MD

OTHER