Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ofatumumab infusion · 1 trial · 1 indication
Tolerability of ofatumumab in combination with chlorambucil was evaluated based on the number of participants who developed toxicity requiring discontinuation from study treatment during Cycle 1. The treatment was considered tolerable when 0 of 3 participants, or \<=2 of 6 participants developed toxicity which required discontinuation of study treatment during Cycle 1. The toxicity requiring discontinuation was determined based on the pre-defined withdrawal criteria.
Response evaluated as per International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-sponsored Working Group (NCI-WG) Guidelines, 2008. Overall response rate (ORR) is defined as percentage of par. achieving complete remission (CR), nodular partial remission (nPR), CR-incomplete (CRi) or PR. CR (\>=2 months after last treatment): lymphocytes (LC) \<4000 per microliter (μL), no lymphadenopathy (Ly)\>1.5 cm/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils (N)\>1500/µL, platelets (PL)\>100,000/µL, hemoglobin (Hb)\>11 grams/deciliter (g/dL), bone marrow (BM) sample must be normocellular for age,\<30% LC, no lymphoid nodule (LN). PR:\>=50% decrease in LC, Ly, size of liver and spleen; and at least one of these: N\>1500/μL, PL\>100,000/µL or 50% improvement over Baseline (BL), Hb\>11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity.
| Arm | Type | Description |
|---|---|---|
| ofatumumab + chlorambucil | EXPERIMENTAL | ofatumumab dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days; chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 treatment cycles |
| Name | Type | Description |
|---|---|---|
| chlorambucil, tablets | DRUG | 2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles |
| ofatumumab (GSK1841157) infusion | DRUG | iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days; |
Inclusion Criteria: * Diagnosis of CLL defined by : Circulating B lymphocytes ≥5,000 /μL AND Flow cytometry confirmation of immunophenotype with CD5, CD19, CD20, and CD23 prior to Visit 2. * Considered inappropriate for fludarabine-based therapy * Active disease and indication for treatment based o...
Ofatumumab infusion is used for chronic lymphocytic leukemia, a type of blood cancer. It is being studied in combination with chlorambucil in previously untreated Japanese patients with this condition. The drug is currently in Phase 2 clinical development.
GSK plc, traded on the London Stock Exchange under the ticker GSK, is developing ofatumumab infusion. The company is conducting clinical trials to evaluate the drug for the treatment of chronic lymphocytic leukemia.
Ofatumumab infusion is in Phase 2 clinical development. It has completed one Phase 2 trial, which was an open-label study in Japanese patients with chronic lymphocytic leukemia. The drug is investigational and not yet approved.
Ofatumumab infusion has one completed clinical trial, NCT01563055, a Phase 2 open-label study of ofatumumab added to chlorambucil in previously untreated Japanese patients with chronic lymphocytic leukemia. The trial enrolled 10 participants and was conducted in Japan.
Ofatumumab infusion is a formulation of ofatumumab, a monoclonal antibody. While the drug name includes 'infusion' to indicate its route of administration, it refers to the same active substance. The clinical trial NCT01563055 evaluates ofatumumab infusion in chronic lymphocytic leukemia.