This trial is evaluating whether lenalidomide will improve 1 primary outcome and 4 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of 30 months.
This trial requires 38 total participants across 2 different treatment groups
This trial involves 2 different treatments. Lenalidomide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
The incidence of lymphoma in the USA has been falling since the early 1970s; however, it remains a significant public health problem with more than 20,000 new cases diagnosed in America in 2005, which is an increase against the 1975 rate. This is despite a decrease in PBL, which is the most common type. This result is the result of improved detection efforts and earlier diagnosis which in turn leads to a lower number of new cases being seen in secondary care. The USA is unlikely to achieve reductions in lymphoma incidence.
There are no common treatments for both cutaneous and non-cutaneous lymphomas. Cutaneous lymphomas account for about 25% of lymphomas and are treated by chemotherapy alone or in some cases, combined with radiation treatments, immunotherapy, immunochemotherapy or a combination of these. Non-cutaneous lymphomas can be treated with steroids with or without chemotherapy, and in some cases, radiation therapies only. The optimal treatment for lymphoma depends on the subtype and the patient's disease stage at the time of diagnosis and treatment. Other treatments include surgery. There are multiple lymphoma types. Lymphoma treatments have changed over the years.
Lymphoma can be cured; however, this is only achieved in a small proportion of cases. A combination of the current therapeutic approach, chemotherapy, with the use of rituximab, a drug designed to target B-cell surface receptors, is the most effective treatment for lymphoma.
About one out of every three men between 15-39 years old will probably develop lymphoma by the age of 65, while about one in three women of this age group will receive a diagnosis of lymphoma at some time. At the same time, the risk for developing lymphoma seems to be higher if the mother was diagnosed with Hodgkin's lymphoma during pregnancy. Lymphoma in children and adolescents may come with a tendency towards other malignancies, such as Hodgkin's lymphoma or leukaemia.
A variety of physical changes may occur as a result of cancer, such as changes in the size of the eyes or ears. A change in the colour of the mucosa of the mouth may also occur. Other possible signs of lymphoma include the feeling of a lump or lump in the body. Narrowing of the opening of one of the rectal openings may also occur, causing people with lymphoma to lose stool through the opening. Lymphoma may also be evident on an X-ray of the brain, where there may be signs of swelling around major arteries. Lymphoma will often cause severe pain, which may cause nausea, sweating and shortness of breath.
Lymphomas, especially lymphomas involving the central nervous system, are of particular concern because they have a high risk of spread to the brain. The WHO recommends MRI scans for patients diagnosed with a tumor of the central nervous system, and lymphatic mapping in these cases.
Results of this preliminary study revealed risk factors for a number of lymphomas, but it is necessary to replicate these findings and investigate the contribution of the main risk factors in future studies. The most common cause of NHL in the population studied was infectious causes.
Results from a prospective study did not demonstrate the occurrence of familial disease among all patients having a diagnosis of NHL or its variants. The study results are compatible with current recommendations, that the most common familial occurrence is the inheritance of a single tumor type, with a slight predisposition toward breast and skin tumors.
Lenalidomide treatment is associated with a significant improvement in quality of life. The effect is dose-dependent, and there is no difference between the 40% or 100% dose levels.
Lenalidomide is approved in the European Union (EU) and the US for the treatment of people with myelodysplastic syndrome. In 2011 the FDA approved it for the treatment of people with chronic lymphocytic leukaemia (CLL) who have had at least two previous lines of treatment. Lenalidomide may be used as a first-line therapy in follicular lymphoma. However, there is no well-designed clinical trial to demonstrate equivalency of lenalidomide to other chemotherapy regimens in people with follicular lymphoma. In this retrospective study, lenalidomide was used as first-line therapy in people with follicular lymphoma.
Despite all the advances in cancer research in the 20th century, there have been no gains in the understanding of the disease and its biology and, as such, the treatment has remained largely unrefined with a high degree of individualization. This may explain why the quality of treatments has remained dismal with the 5-year relative survival only 20% with all modal treatments and 16% with a combination of treatments.
On the pooled basis, our meta-analysis showed that lenalidomide did not provide greater improvement than placebo in terms of objective response or rate of remission but it had fewer side effects than ondansetron and provided higher response rates. Long-term safety and quality of life will also need to be evaluated.