This trial is evaluating whether Filgrastim-sndz will improve 2 primary outcomes and 4 secondary outcomes in patients with Precursor T-Cell Lymphoblastic Leukemia-Lymphoma. Measurement will happen over the course of Up to 30 days after last dose.
This trial requires 40 total participants across 1 different treatment group
This trial involves a single treatment. Filgrastim-sndz 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 most common treatments used In a recent study were chemotherapy and peripheral blood stem cell transplantation. In cases where multicentric disease was present, surgery or radiation therapy were also used. When a patient had multiple sites of disease, the order of treatment varied according to the degree of involvement at each site. For all patients, the first line regimen consisted of prednisone plus methotrexate, followed by six weeks of cytarabine." - Anonymous Online Contributor
"Pegfilgrastim therapy was well tolerated In a recent study population; however, common adverse events included infection (56%), infusion-related reactions (49%) and fever (37%); most occurred during the first 6 weeks of therapy. No serious infectious complications were reported. Serious infections were found in <1% of patients who received pegfilgrastim. The incidence of serious infusion-related reactions was higher in infants than in adults, but no differences between genders were observed." - Anonymous Online Contributor
"Pegfilgrastim is a growth factor produced by a bacterial species, Bacillus cereus strain ATCC 14579, which is used as an anticancer drug. The FDA approved pegfilgrastim for use in adults and children with chemotherapy-induced neutropenia. Because of its unique structure, pegylated filgrastim offers a number of advantages over conventional filgrastim such as improved bioavailability, reduced frequency and severity of adverse events, lower cost and elimination of the need for regular filgrastim dosing. In addition, pegfilgrastim presents a low risk of infusion-related reactions compared with filgrastim." - Anonymous Online Contributor
"Pegfilgrastim showed the same efficacy as a control in preventing febrile neutropenia with a higher incidence of infection when compared to placebo. This result suggests that pegfilgrastim cannot be recommended for this indication." - Anonymous Online Contributor
"Findings from a recent study shows that a CD5+CD19+ T-LBL proband has a unique genetic profile, indicating that there may be different disease pathways among these cases. We suggest that this study may provide new insights into the pathogenesis of the disease along with its critical implication for future diagnosis and treatment." - Anonymous Online Contributor
"Between 1995 and 2003, the number of new cases per year increased more than three-fold from 5.0 to 16.4 for PTCLL. Many children diagnosed with PTCLL were young (median age 10 years) and were hospitalized. The proportion of PTCLL patients who underwent allogeneic hematopoietic stem cell [transplant](https://www.withpower.com/clinical-trials/transplant)ation was low; however, the survival rates after HSCT were excellent. The incidence of PTCLL declined after 2000, probably because of reductions in drug exposure and rising awareness among physicians." - Anonymous Online Contributor
"The average age at diagnosis for PTLL/T-PLL is 46 years (range 10-79 years). PTLL/T-PLL has been reported in individuals up to 79 years old. Most cases occur in adults or adolescents; however, PTLL/T-PLL can arise in children under the age of 10 years. The presentation of this disease is variable. Symptoms are typically nonspecific. Abnormal findings on an individual's examination may include enlargement of one or more lymph nodes, enlarged spleen, paracentesis, elevated creatinine, bone marrow involvement, bone lesions, and hepatomegaly." - Anonymous Online Contributor
"The percentage of patients who had received pegfilgrastim prior to participation in the current trial was approximately 50%. Because the majority of these patients were treated as outpatients at the study center, it is possible that more suboptimal doses of pegfilgrastim could have been used in the study population compared with actual use in hospitalized patients. The available data suggest that pegfilgrastim reduces the number of febrile neutropenic episodes in children with acute lymphocytic leukemia when given at a dose of 40 microg/kg per day. In addition, pegfilgrastim is effective when used for prophylaxis in children with moderate to severe chronic myelogenous leukemia who are receiving maintenance therapy." - Anonymous Online Contributor
"Survival rates are improving due to advances in the treatment of precursor T-cell lymphoblastic leukemia-lymphoma. In addition, the current FIGO staging system is influencing survival outcomes for patients with this cancer." - Anonymous Online Contributor
"It is likely that PTCLL was introduced into Europe around 2000 through immigration from South America. Over the last decade we observed a significant increase in the number of patients diagnosed with PTCLL. This finding was accompanied by an increase in the number of countries reporting new cases of PTCLL. There is a need for national data collection to monitor and estimate trends in PTCLL incidence and diagnose more cases to provide evidence on its epidemiology and management." - Anonymous Online Contributor
"The use of pegfilgrastim in combination with chemotherapy and radiotherapy is not common. Therefore, we recommend obtaining formal approval for all patients before starting pegfilgrastim therapy." - Anonymous Online Contributor