Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01108341 | Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL) | PHASE2 | COMPLETED | 50 | — | — | May 1, 2010 | Oct 1, 2011 | Aug 28, 2012 | 39 | United States, Belgium +1 |
The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
| Arm | Type | Description |
|---|---|---|
| Bendamustine and Ofatumumab | EXPERIMENTAL | There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m\^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles. |
| Name | Type | Description |
|---|---|---|
| Bendamustine hydrochloride | DRUG | Bendamustine will be administered at 90 mg/m\^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle. |
| Ofatumumab | DRUG | Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle. |
Key Inclusion Criteria: * The patient has histopathologic confirmation of one of the protocol-specific CD20+ B-cell non-Hodgkin's lymphomas. Tissue diagnostic procedures must be performed within 6 months of study entry and with biopsy material available for review. * The patient meets 1 of the foll...