Trial of Single Agent Ofatumumab in Relapsed / Refractory Mantle Cell Lymphoma
Plymouth, Leeds, Leicester and Glasgow.
Mantle cell lymphoma has the worst prognosis of all sub-types of Non-Hodgkin's lymphomas, with a 5 year survival rate of around 27%. Many patients will respond to first line treatment, but this response is rarely complete and the patients are likely to relapse. Additional treatment is often inadequate and further relapse is to be expected. This study will investigate the response of patients to single agent Ofatumumab (a new generation CD20 antibody) following relapse or refractory to at least 1 prior treatment regimen.
This study will investigate the response of patients to single agent Ofatumumab (a new generation CD20 antibody) following relapse or refractory to at least 1 prior treatment regimen. This trial is the first to use Ofatumumab in MCL, but when used in patients with CLL Ofatumumab demonstrated a 20 - 63% response rate, most of which followed previous treatment with Rituximab.
The primary objective is to evaluate the overall rates of overall response (CR, Cru and PR).
Secondary objectives are to evaluate the duration of response, to determine the median time to progression, to determine the median overall survival, to evaluate the toxicity and tolerability of the research treatment.
A trial patient information sheet and any local information on relapsed mantle cell lymphoma will be given to eligible patients when relapse is confirmed.
Patients offering informed consent will be registered into the trial. All patients will receive Ofatumumab once a week for a maximum of 5 weeks; the first dose will be lower than the following four, in order to test the initial reactions to the drug, which has the potential to give allergic type side effects. For this reason all patients will be given a pre-medication, before each infusion, based on the reactions from the previous infusion. Dose modifications for toxicity are built into the protocol. Patients will be followed for progression and overall survival.
Patients with a confirmed mantle cell lymphoma, who have relapsed following, or who are refractory to, at least 1 prior chemotherapy regimen. Any previous chemotherapy regimen is permissible. Previous localised RT or splenectomy is also permissible. Patients must have measurable disease and adequate bone marrow, liver and kidney function.
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