Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OFC Infusion · 1 trial · 1 indication
PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (progressive disease,PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (\>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia (CLL).
| Arm | Type | Description |
|---|---|---|
| Ofatumumab, Fludarabine, Cyclophosphamide | EXPERIMENTAL | Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles |
| Fludarabine, Cyclophosphamide | ACTIVE_COMPARATOR | Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles |
| Name | Type | Description |
|---|---|---|
| OFC Infusion | DRUG | Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles |
| FC infusion | DRUG | Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250mg/m2 Days 1-3 every 28 days for 6 cycles |
Key Inclusion Criteria: * confirmed and active CLL requiring treatment * at least one previous treatment for CLL and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression * fully active at a minimum or fully capable of...
OFC Infusion is used for chronic lymphocytic leukemia, a type of blood cancer. It is being studied as an investigational treatment in patients with relapsed chronic lymphocytic leukemia, meaning the disease has returned after prior therapy.
OFC Infusion is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research on this investigational therapy for chronic lymphocytic leukemia.
OFC Infusion is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials for safety and efficacy in patients with chronic lymphocytic leukemia.
OFC Infusion has one completed Phase 3 clinical trial, registered as NCT00824265. This trial enrolled 365 participants and compared ofatumumab added to fludarabine-cyclophosphamide versus fludarabine-cyclophosphamide alone in relapsed chronic lymphocytic leukemia patients.
OFC Infusion is a formulation of ofatumumab, a small molecule drug. The clinical trial NCT00824265 specifically evaluated ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed chronic lymphocytic leukemia, indicating that OFC Infusion refers to this ofatumumab-based regimen.