This trial is evaluating whether MAK683 will improve 2 primary outcomes and 8 secondary outcomes in patients with Lymphoma, Large B-Cell, Diffuse. Measurement will happen over the course of up to day 15.
This trial requires 203 total participants across 2 different treatment groups
This trial involves 2 different treatments. MAK683 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 1 & 2 and have already been tested with other people.
The incidence of diffuse large-cell lymphoma in the United States is approximately 10 cases per 100,000 or more. It also varies across racial/ethnic groups. In the United States, lymphoma, large-cell, diffuse accounts for approximately 5% of all lymphomas. Around 15-20% of cases are not in individuals who are younger than 40 years at diagnosis, and about 75% of cases appear to have an adverse prognosis.
LCLD has a variable clinical picture. Initial signs of the disease may include fever, night sweats, weight loss, malaise and adenopathy. Other common signs include headache, night sweats, malaise, and weight loss. The diagnosis can be made on clinical grounds (e.g. lymphadenopathy) by correlating them with the blood test data. The diagnosis can also be made by pathological examination of tissue slides. Patients with LCLD have a high incidence of complications. Treatment of the complication is crucial; usually necessitating surgery. Early disease may be mistaken for LCLD; staging and investigation thus have to be done early.
Despite advances in treatment, large B-cell, diffuse lymphomas may not be curable. For patients whose disease progresses after initial treatment response, no chemotherapy regimen has been shown to be superior to others, though newer chemotherapy regimens may be needed for treatment resistant disease.
Lymphoma patients tend to receive a combination of immuno- and chemotherapeutic agents before and during radiation therapy. Chemotherapy and radiotherapy used in the treatment of patients with diffuse large B-cell lymphoma tend to involve the same chemotherapy agents as used against Hodgkin disease (HL).
Lymphoma, large b-cell, diffuse is not fully understood, but is thought to be caused by infection with human T-cell leukemia virus type 1 (HTLV-I) and Epstein-Barr virus (EBV), or by some defect in cell-mediated immunity to these agents. These include a lack of B cells, which produce IL-4, a growth factor that promotes the survival of CD4+ T cells and inhibits multiplication and survival of B cells.
LBCD is a newly described subtype of diffuse large B-cell lymphoma that is characterized by a distinct clinical spectrum when compared with other B-cell lymphomas, typically presenting as a younger age group than other subtypes of DLBCLs.
On average, lymphoma, large b-cell, diffuse is diagnosed in 70 years old women. There is no differences between all geographic regions, age and stage. If you are looking to join a lymphoma clinical trial, Power can help you search recent trials by condition, treatment, or location.
Lymphoma, large-b-cell, diffuse spreads mostly within 2 years. Most patients with lymphoma, large-b-cell, diffuse survive at least three years. A large lymphoma registry database is required to more consistently assess patterns of care.
Results from a recent paper highlights the importance of pharmacokinetic/pharmacodynamic modeling in the development of optimal dosing for novel biotherapeutics. Results from a recent paper indicate that the development of therapeutic dosing regimens of mak683 is more challenging than anticipated and may require the establishment of a dosing regimen other than the current schedule.
In a recent study, findings, the most frequent (≥4%) adverse events reported in patients given mak683 were fatigue, decreased appetite, and diarrhea. All of these events were mild or moderate in severity and did not preclude the completion of treatment. Considering clinical practice and the low rate or severity of these AEs relative to the frequency and severity of other adverse effects observed in patients treated with mak683, it is unlikely that they adversely affect mak683 overall benefit, although further research will be necessary to confirm this.
There is only one clinical trial for patients with lymphoma, large b-cell, diffuse and the latest research was published in June 1998, meaning [there have been (not) many studies over the last three or so years that support or refute the clinical trial findings of this particular study]. There were no positive trials found that indicated that chemotherapy could improve survival with chemotherapy, so [there is] only one study that deals with patient treatment with large-b-cell lymphoma, diffuse, so it will be difficult to determine the current state of the research for lymphoma, large b-cell, diffuse.