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Also known as ofatumumab (GSK1841157) infusion
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 being studied for the treatment of chronic lymphocytic leukemia, a cancer of the blood and bone marrow. The clinical program described here focuses on previously untreated Japanese patients with this condition. It is an investigational monoclonal antibody therapy in Phase 2 development.
Ofatumumab infusion targets MS4A1, also known as CD20, a protein found on the surface of B cells. By binding this target, the antibody is designed to act against the malignant B cells that characterize chronic lymphocytic leukemia. MS4A1 is the molecular target listed for this monoclonal antibody.
Ofatumumab infusion is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor behind the clinical program for this monoclonal antibody in chronic lymphocytic leukemia.
Ofatumumab infusion is in Phase 2 development. It is an investigational therapy and is not described as approved. The program includes one completed Phase 2 trial, with no active trials currently listed.
Ofatumumab infusion has been evaluated in one completed trial, NCT01563055. This Phase 1/2, open-label study tested ofatumumab added to chlorambucil in previously untreated Japanese patients with chronic lymphocytic leukemia. It enrolled 10 participants in Japan and was an uncontrolled study without randomization or blinding.
Yes, ofatumumab infusion is also known as ofatumumab (GSK1841157) infusion. GSK1841157 is the internal development code used by GSK plc for this monoclonal antibody. Both names refer to the same investigational therapy targeting MS4A1 in chronic lymphocytic leukemia.