Phase II single agent Lenalidomide (Revlimid®) in relapsed / refractory mantle cell
Plymouth Hospitals NHS Trust & St Bartholomew's Hospital, London
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 within 18 months. Additional treatment is often inadequate and further relapse is to be expected. This study will investigate the response of patients to single agent Lenalidomide (Revlimid®) following relapse or refractory to at least 2 prior treatment regimens. Single agent Lenalidomide has previously demonstrated a 31% overall response rate when given to 16 patients with relapsed Non-Hodgkin's Lymphoma.
Lenalidomide, an oral drug taken once daily at night
The primary objective is to evaluate the 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 Lenalidomide, starting at 25mgs per day. Dose modifications for toxicity are built into the protocol. In the treatment phase, 6 cycles, each of a 28- day duration will be given, with restaging after 3 and 6 cycles. Depending upon response to treatment and toxicity, the patient may continue Lenalidomide in the aintenance phase of the trial. In this phase, the dose will be reduced to 15 mg per day or the lowest dose the patient had tolerated during the treatment phase, whichever is the lower. 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, two or more chemotherapy regimens.
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