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TropicALL study: Thromboprophylaxis in Children treated for Acute Lymphoblastic Leukemia with Low-molecular-weight

Irene L M Klaassen1,2, Mandy N Lauw2,3, Marianne D van de Wetering4

  • 1Department of Pediatric Hematology, Academic Medical Center, Amsterdam, The Netherlands.

BMC Pediatrics
|May 11, 2017
PubMed

Insights

This randomized trial investigates if low-molecular-weight heparin (LMWH) prevents venous thromboembolism (VTE) in children with acute lymphoblastic leukemia (ALL) receiving asparaginase. Results will guide VTE prophylaxis during ALL treatment.

Area of Science:

  • Hematology
  • Pediatric Oncology
  • Clinical Trials

Background:

  • Venous thromboembolism (VTE) is a significant complication in acute lymphoblastic leukemia (ALL) treatment, often linked to asparaginase.
  • Previous studies suggest low-molecular-weight heparin (LMWH) prophylaxis reduces VTE risk with minimal bleeding.
  • A randomized controlled trial is needed to confirm LMWH efficacy in pediatric ALL.

Purpose of the Study:

  • To evaluate the efficacy and safety of LMWH thromboprophylaxis versus no prophylaxis in children with ALL.
  • To determine the impact of LMWH on VTE incidence during asparaginase treatment.
  • To assess bleeding risks associated with LMWH in this pediatric population.

Main Methods:

  • A multicenter, randomized controlled open-label trial (TropicALL) in the Netherlands.
  • Patients aged 1-19 with primary ALL randomized to LMWH (85 IU/kg daily) or no prophylaxis during asparaginase therapy.
  • Primary endpoint: symptomatic VTE; secondary endpoints: overall survival, asymptomatic VTE, and bleeding events. Sample size: 324 patients.

Main Results:

  • This section is not available in the provided abstract.
  • Further analysis is required to present the main results.
  • The study is designed to detect a 75% relative risk reduction in VTE.

Conclusions:

  • This trial represents the first randomized assessment of LMWH thromboprophylaxis during asparaginase treatment for pediatric ALL.
  • Findings will provide crucial evidence for optimizing VTE prevention strategies in children undergoing ALL therapy.
  • The study aims to establish a new standard of care for VTE prophylaxis in this vulnerable group.
Abstract

Keywords:
Acute lymphoblastic leukemiaAsparaginaseLow molecular weight heparinPediatricVenous thromboembolic disease

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