This trial is evaluating whether Gilteritinib will improve 2 primary outcomes and 6 secondary outcomes in patients with Myelodysplastic Syndromes. Measurement will happen over the course of Up to 28 days.
This trial requires 42 total participants across 1 different treatment group
This trial involves a single treatment. Gilteritinib 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.
"In patients who received gilteritinib for CLL, improved QOL was observed as compared with historical controls. Recent findings provide preliminary evidence that gilteritinib is well tolerated in patients with chronic lymphocytic leukaemia and might be an effective therapeutic option." - Anonymous Online Contributor
"Survival rates for leukemia, myeloid, acute were very good with more than 90% surviving after 15 years. There was a significant difference in survival rate based on age where patients over 100 had a significantly lower survival rate than those under the age of 50. Patients with myeloid and acute leukemias were found to live longer than those who had acute lymphocytic leukemia." - Anonymous Online Contributor
"In vitro and in vivo data support that gilteritinib acts directly on JAK2; this action appears to be mediated by inhibition of downstream signaling events involving STAT3 activation. Combining gilteritinib with other agents targeting PI3K/Akt or STAT3 may be beneficial in the treatment of myeloproliferative neoplasms (MPNs)." - Anonymous Online Contributor
"The most commonly used combination regimen consists of gilteritinib plus lenalidomide or pomalidomide. In patients treated with these combinations, the most commonly reported adverse events were neutropenia and fatigue." - Anonymous Online Contributor
"Gilteritinib (commonly known by its trade names Tykerb, Gilotrif, Sipuleucel-T) is an oral medication used to treat certain types of non-Hodgkin lymphoma (NHL). It binds to the BCR protein on B cells and inhibits the growth of these cells. In clinical trials, gilteritinib has shown efficacy against follicular NHL (FL), DLBCL, MCL, and hairy cell leukaemia (HCL) when used alone or in combination with rituximab, chlorambucil, cyclophosphamide, or bendamustine." - Anonymous Online Contributor
"Gilteritinib monotherapy was associated with significant improvement compared with placebo monotherapy for all primary endpoints evaluated In a recent study. The modest magnitude of improvements seen In a recent study suggests the need for larger studies to confirm these results." - Anonymous Online Contributor
"The median age people get leukemia is 62 years old; however, this increases with gender (male: 63 years old vs female: 57 years old), ethnicity (white: 62 years old vs black: 60 years old), and ethnicity (Hispanic: 59 years old vs Asian: 58 years old)." - Anonymous Online Contributor
"Gilteritinib treats a variety of hematologic malignancies including acute myeloid leukemia and chronic myeloid leukemia. It also may be useful as a second line therapy for patients with relapsed or refractory mantle cell lymphoma. Gilteritinib is used at doses of 200mg once per day, (dosed according to body surface area) or 400mg twice daily. Patients who require more than one dose per day must take a break between doses of less than 24 hours. Additionally, the drug cannot be taken during pregnancy or breastfeeding due to potential harm to the fetus or child. Side effects include diarrhea, nausea, loss of appetite, rash, joint pain, vomiting, and constipation." - Anonymous Online Contributor
"Clinical trials are needed for all patients with AML and MDS. Patients with MDS should be considered for clinical trials because they have an increased risk of death due to their disease as well as the development of complications." - Anonymous Online Contributor
"While [many researchers have attempted to develop new treatments for leukemia, myeloid, acute] (https://www.nhlbi.nih.gov/news/chda/2016/04/07/leukemia-myeloid-acute/), none have fulfilled the goal recently. It is important to continue researching, as it will hopefully lead to a more effective way of treating leukemia, myeloid, acute.\n" - Anonymous Online Contributor
"No clinical studies have investigated gilteritinib in combination with other agents; however, the evidence suggests that gilteritinib may be effective when combined with other cytotoxic chemotherapy drugs such as bortezomib, lenalidomide, thalidomide, and pomalidomide. Therefore, it may be worth considering gilteritinib for patients with relapsed or refractory AML who receive more than one prior chemotherapeutic regimen. Additional studies are warranted." - Anonymous Online Contributor