BRALLA protocol

Recruiting

• Conditions: Acute lymphoblastic leukemia; C04.557.337

• Registration Number: RBR-10jpb6v7
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-13
• Last Update Posted: 18 September 2023
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients between 16 and 50 years-old; both genders; with newly diagnosed Acute Lymphoblastic Leukemia - ALL; negative for Philadelphia chromosome; not previously treated (except for hydroxyurea, corticosteroids, or intrathecal chemotherapy) with at least 20% blasts in peripheral blood and/or bone marrow

Exclusion Criteria

Burkitt leukemia. Prior chronic myeloproliferative disease. Philadelphia chromosome positivity. ECOG>2. Total bilirubin>2x upper limit of normality. Transaminases>5x ULN. Creatinine>2,5 mg/dl. Positive serology for HIV or HTLV. Heart failure NYHA Class III or IV. Severe psychiatric disorder which prevents adequate compliance. Prior treatment with intravenous chemotherapy, except for hydroxyurea and corticosteroids. Refusal to participate in the study. Down syndrome

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Examine whether the implementation of a pediatric protocol under a prospective registry can increase 3-year event-free survival in this population from 45% to 60%.

Secondary Outcome Measures

Name	Time	Method
To compare OS and EFS of this cohort with other publications from developed countries and with our historical cohort before this study. ;To develop a cooperative network for ALL treatment, aiming to Exchange experiences and ranking of priorities regarding this disease in our country. ;Provision of molecular and cytogenetic complementation for all included patients, allowing an increased classification of newly diagnosed cases. ;To address the prognostic impact of MRD on EFS and OS when measured in two timepoints throughout the treatment. ;To evaluate the cumulative incidence of allogeneic hematopoietic stem-cell transplantation (HSCT) over the treatment for all eligible patients. ;To determine prognostic factors for EFS, OS and relapse in adult ALL. To describe main death causes and predictors of non-relapse mortality. ;To build a biorepository of leukemia samples at the diagnosis, aiming to develop further translational studies on this population.