Influence of drug use on the performance of chemoterapy treatment in children with cancer
Phase 3
Recruiting
- Conditions
- Acute Lymphoblastic Leukemia
- Registration Number
- RBR-9d5t69p
- Lead Sponsor
- Hospital de Clínicas de Porto Alegre
- Brief Summary
Event-free survival and overall survival; Minimal Residual Disease Response (MRD): Defined as MRD level < 10-4 at the end of treatment; Cumulative relapse incidence; Asparaginase inactivation incidence; Incidence of PEG-asparaginase hypersensitivity reactions with and without premedication.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
Patients who do not accept to participate; do not use PEG (polyethylene glycol) asparaginase; over 21 years old
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.