Acute Lymphoblastic Leukemia
Conditions
Interventions
The patients will be divided into two groups, an experimental group and a control group.
Experimental group: 220 Brazilian children under 21 years of age undergoing first-line (first-time) treatment f
D08.811.277.087.116
Sponsors
Hospital de Clínicas de Porto Alegre
Servier
Eligibility
Age
No minimum to 21 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with acute lymphoblastic leukemia; in the first line of treatment; under 21 years of age; using PEG (polyethylene glycol) asparaginase; both gender
Exclusion criteria
Exclusion criteria: Patients who do not accept to participate; do not use PEG (polyethylene glycol) asparaginase; over 21 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We intend to evaluate the influence of premedication on PEG (polyethylene glycol) asparaginase activity in Brazilian children undergoing first-line treatment for ALL (acute lymphoid leukemia). Categorical variables will be analyzed and reported with percentages. Differences between groups will be assessed using the chi-square test. | — |
Secondary
| Measure | Time frame |
|---|---|
| We intend to evaluate Event Free Survival (SLE), calculating from the moment of diagnosis until the date of relapse or bone marrow M2 after achieving complete remission (CR). In order to assess Global Survival (SG) the calculation will be made from the time of diagnosis until death from any cause. It will be done by the Mann-Whitney test.;To evaluate the incidence of hypersensitivity reactions with PEG (polyethylene glycol) asparaginase with and without premedication. It will be done by the chi-square test. | — |
Countries
Brazil
Contacts
Public ContactMariana;Klerize Michalowski;de Souza Silva
Hospital de Clínicas de Porto Alegre;Universidade Federal do Rio Grande do Sul
Outcome results
None listed