Approval Probability
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Adjusted LOA
ML Risk
Ofatumumab/HDMP · 1 trial · 1 indication
Responses were assessed two months after completion of therapy. Criteria for complete remission is assessed with: a bone marrow biopsy and repeat CT scan (abdominal, chest and pelvis if initial was abnormal) to confirm iwCLL-WG defined CR. iwCLL-WG Complete Response is defined as: * Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 x 109/L (4000/L). * Absence of lymphadenopathy (\>1.5 cm)of physical exam; AND * No hepatomegaly and splenomegaly on physical exam; AND * Absence of constitutional symptoms; AND * Normal complete blood count as exhibited by neutrophils ≥ 1,500/μl, platelets \> 100,000/μl, hemoglobin \> 11.0g/dL (non-transfused), and lymphocyte count \< 5,000/μl; AND * Bone marrow aspirate and biopsy must be normocellular for age with \<30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent
| Arm | Type | Description |
|---|---|---|
| Ofatumumab/HDMP | EXPERIMENTAL | High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle. Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered. Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity. |
| Name | Type | Description |
|---|---|---|
| Ofatumumab/HDMP | DRUG | High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle. Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule. Each patient will receive a maximum of 3 cycles (one cycle is 28 days) |
Inclusion Criteria: 1. Previously treated patients with a diagnosis of CLL 2. Previous treatment with any monoclonal antibody or chemotherapy regardless of response as defined by the iwCLL Working Group Guidelines as evidenced by: * progressive marrow failure as manifested by the development of...
Ofatumumab is an investigational drug being studied for use in several blood cancers and autoimmune conditions, including follicular lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis, Waldenstrom macroglobulinaemia, and diffuse large-cell lymphoma. It is developed by GSK plc (GSK) and is currently in Phase 2 clinical development.
Ofatumumab targets CD20, a protein found on the surface of B-cells. By binding to CD20, it is designed to help the immune system attack and destroy these cells, which is relevant in B-cell malignancies and autoimmune diseases. This mechanism is being explored in conditions like follicular lymphoma and chronic lymphocytic leukemia.
Ofatumumab is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology and immunology indications.
Ofatumumab is in Phase 2 clinical development. It has completed four clinical trials, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities for any indication.
Ofatumumab has completed four clinical trials, including NCT00394836 in follicular lymphoma refractory to rituximab, NCT00410163 in B-CLL with fludarabine and cyclophosphamide, NCT00494780 in follicular lymphoma with CHOP, and NCT01110031 a cardiac repolarization study in CLL. All trials are completed.
Yes, Ofatumumab is also known as HuMax-CD20. Clinical trials have used this alternative name, such as NCT00394836 titled 'HuMax-CD20 (Ofatumumab) in Follicular Lymphoma Patients Refractory to Rituximab' and NCT00494780 titled 'Ofatumumab (Humax-CD20) with CHOP in Follicular Lymphoma Patients.'