Chemotherapeutic Toxicity Clinical Trial
— BRALLAOfficial title:
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study
NCT number | NCT05959720 |
Other study ID # | 3011/22 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 5, 2023 |
Est. completion date | June 2030 |
In this project, the investigators intend to start a prospective registry for patients with newly diagnosed Philadelphia-negative ALL from 16 years old and above in participating centers, provided that all patients will be treated with the same regimen (a pediatric regimen BFM-based incorporating peg-asparaginase). All diagnostic/follow-up (after induction and consolidation blocks) samples will be centrally biobanked at Instituto do Cancer do Estado de Sao Paulo. The main goal of this study is to examine whether the implementation of a pediatric protocol under a prospective registry can increase event-free survival (EFS) and overall survival (OS) of newly diagnosed patients in the participating centers.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | June 2030 |
Est. primary completion date | June 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 50 Years |
Eligibility | Inclusion Criteria: Patients between 16 and 50 years-old with newly diagnosed ALL, negative for Philadelphia chromosome not previously treated (except for hydroxyurea, corticosteroids, or intrathecal chemotherapy) with 20% or more lymphoblasts in bone marrow or peripheral blood. Exclusion Criteria: - Burkitt leukemia - Prior myeloproliferative disease - Philadelphia chromosome positivity through whichever methodology (RT-PCR, FISH, or conventional karyotype) - ECOG>2 (appendix 3) - Total bilirubin>2x upper limit of normal (ULN) - Transaminases>5x ULN - Creatinine>2,5 mg/dl - Positive serology for HIV or HTLV - Heart failure NYHA Class III or IV (appendix 4) - Severe psychiatric disorder which prevents adequate compliance - Prior treatment with intravenous chemotherapy - Refusal to participate in the study - Down syndrome |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto do Cancer do Estado de Sao Paulo | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Instituto do Cancer do Estado de São Paulo | Servier |
Brazil,
Silva WF, Amano MT, Perruso LL, Cordeiro MG, Kishimoto RK, de Medeiros Leal A, Nardinelli L, Bendit I, Velloso ED, Rego EM, Rocha V. Adult acute lymphoblastic leukemia in a resource-constrained setting: outcomes after expansion of genetic evaluation. Hematology. 2022 Dec;27(1):396-403. doi: 10.1080/16078454.2022.2052602. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival (OS) | cumulative proportion of patients alive (considering the time between the date of diagnosis and death or last follow-up) | 4 years | |
Secondary | Event-free survival (EFS) | time between enrollment in the study and the occurrence of any event: refractoriness after the first two cycles of induction, death or relapse. | 4 years | |
Secondary | Early death rate | proportion of patients who died before the first bone marrow evaluation of response (after induction I) | 60 days | |
Secondary | Complete response rate | proportion of patients with bone marrow aspirate with less than 5% blasts and evidence of normal hematopoiesis; CSF without blasts and recovery of peripheral blood (neutrophils= 1,000/µL and platelets=100,000/µL), without the need for transfusion | 60 days | |
Secondary | Cumulative incidence of relapse | rate of disease relapse after CR calculated considering death as a competing event. | 4 years | |
Secondary | HSCT rate | proportion of patients eligible for the protocol who were able to perform the procedure in their first CR | 2 years |
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