Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ofatumumab · 1 trial · 1 indication
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...
Ofatumumab is being studied for the treatment of Non-Hodgkin's Lymphoma (NHL), specifically in combination with bendamustine for previously untreated patients with indolent B-cell NHL. It is an investigational therapy in Phase 2 clinical development for this indication.
Ofatumumab is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical research on the drug for Non-Hodgkin's Lymphoma.
Ofatumumab is in Phase 2 clinical development for Non-Hodgkin's Lymphoma. It is an investigational drug and has not been approved by regulatory authorities for this use. One Phase 2 trial has been completed.
Ofatumumab has been studied in a completed Phase 2 clinical trial with the identifier NCT01108341. The trial evaluated the efficacy and safety of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-cell Non-Hodgkin's Lymphoma.
Ofatumumab is a distinct drug entity. It is being investigated for Non-Hodgkin's Lymphoma and is not known to be identical to any other marketed or investigational drug under a different name.