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Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil

Study acronym: BRALLA
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Start date changed from estimate of Aug 2023 to Sep 5, 2023v4
  3. Start date: Jul 2023 to Aug 2023v3
  4. Study description expanded, about 2 words
    • Study title shortened, about 5 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05959720
Lead Sponsor Instituto do Cancer do Estado de São Paulo
Collaborators: Servier
Conditions
(from sponsor)		 Acute Lymphoid Leukemia, Minimal Residual Disease, Gene Abnormality, Chemotherapeutic Toxicity
Related terms Neoplasm, Residual, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov