Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PI3K inhibitor BKM120 · 1 trial · 9 indications
Summarized and tabulated by dose level.
| Arm | Type | Description |
|---|---|---|
| Treatment (PI3K inhibitor BKM120, rituximab) | EXPERIMENTAL | Patients receive BKM120 PO daily and rituximab IV. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with asymptomatic progression may continue treatment for up to 12 months. Pharmacodynamic samples from peripheral blood (for those with peripheral blood involvement) and bone marrow aspirate (for all patients) are drawn at baseline. Patients will undergo correlative studies to include bone marrow biopsy at study enrollment, and at the time of complete remission. |
| Name | Type | Description |
|---|---|---|
| PI3K inhibitor BKM120 | DRUG | 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 |
| rituximab | BIOLOGICAL | 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. |
| Pharmacodynamics | OTHER | Pharmacodynamic samples from peripheral blood (for those with peripheral blood involvement) and bone marrow aspirate (for all patients) are drawn at baseline. |
| Correlative studies | OTHER | 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. |
Inclusion Criteria: * Patients must have histologically confirmed indolent B-cell NHL or mantle cell lymphoma; acceptable subtypes of indolent B-cell NHL include follicular lymphoma (grades 1, 2, or 3a), marginal zone lymphoma, or lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia; patients...