Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Oct;72(10):e31886.
doi: 10.1002/pbc.31886. Epub 2025 Jul 9.

Results of a Randomized Augmented Intensification Phase in Acute Lymphoblastic Leukemia in Children in Argentina: GATLA 2010 ALL IC Trial

Maria C Riccheri  1 , Sergio M Gomez  2 , Alejandra Deana  1 , Alcira B Fynn  2 , Pedro Negri-Aranguren  3 , Guillermo Arbesu  4 , Graciela Elena  5 , Horacio Caferri  6 , Alejandra Cedola  7 , Marcela Soria  8 , Paola Reichel  9 , Monika Makiya  10 , Carlos Hollmann  10 , Sandra Borchichi  11 , Cristina Ferraro  8 , Virginia Schuttenberg  2 , Mercedes Tomassetti  12 , Mae Arrieta  13 , Eduardo Dibar  10 , Lillian Sung  14
Affiliations
Clinical Trial

Results of a Randomized Augmented Intensification Phase in Acute Lymphoblastic Leukemia in Children in Argentina: GATLA 2010 ALL IC Trial

Maria C Riccheri et al. Pediatr Blood Cancer. 2025 Oct.

Abstract

Background: Intensified postinduction therapy improves outcomes for high-risk pediatric patients with acute lymphoblastic leukemia (ALL) in high-income countries. However, benefits are uncertain in middle-income countries where supportive care is often limited. The primary objective was to determine if augmented protocal I phase B (IB) reduced the 5-year cumulative incidence of relapse compared with standard IB among newly diagnosed pediatric patients with intermediate- and high-risk (IR and HR) ALL in a middle-income country.

Methods: This was a randomized, phase III multicenter study conducted in 30 centers from GATLA group in Argentina, as part of International BFM study group ALLIC. We included newly diagnosed pediatric patients with ALL 1-18 years of age with IR or HR B- and T-precursor ALL. Only patients who were in complete remission at end induction were randomized to augmented IB versus standard IB. Augmented IB consisted of cyclophosphamide, cytarabine, 6-mercaptopurine, vincristine, E. coli l-asparaginase and intrathecal methotrexate. Standard IB consisted of cyclophosphamide, 6-mercaptopurine, cytarabine, and intrathecal methotrexate. The primary outcome was the cumulative incidence of relapse.

Results: There were 1060 patients randomized to standard IB (n = 527) and augmented IB (n = 533). The 5-year cumulative incidence of relapse (±standard error) was not significantly different by group (22.6 ± 0.2 vs. 22.3 ± 0.1%; p = 0.97) for standard IB and augmented IB, respectively. Treatment-related mortality (TRM) was 6.5 ± 0.1 and 7.5 ± 0.1%; p = 0.45, respectively.

Conclusions: Among newly diagnosed pediatric patients with IR and HR ALL treated in Argentina, postinduction intensification with augmented IB did not improve outcomes compared with standard IB. Standard IB should be used for these patients. Future trials should focus on reducing TRM.

Keywords: Argentina; acute lymphoblastic leukemia; children; randomized intensification.

PubMed Disclaimer

References

    1. C. H. Pui, J. J. Yang, S. P. Hunger, et al., “Childhood Acute Lymphoblastic Leukemia: Progress Through Collaboration,” Journal of Clinical Oncology 33 (2015): e1600–e1606.
    1. C. H. Pui, “Precision Medicine in Acute Lymphoblastic Leukemia,” Frontiers of Medicine 14 (2020): 689–700.
    1. M. Campbell, C. Kiss, M. Zimmermann, et al., “Childhood Acute Lymphoblastic Leukemia: Results of the Randomized Acute Lymphoblastic Leukemia Intercontinental‐Berlin‐Frankfurt‐Münster 2009 Trial,” Journal of Clinical Oncology 41, no. 19 (2023): 3499–3511.
    1. M. Navarrete, E. Rossi, E. Brivio, et al., “Treatment of Childhood Acute Lymphoblastic Leukemia in central America: A Lower‐middle Income Countries Experience,” Pediatr Blood Cancer 61, no. 5 (2014):803–809.
    1. N. L. Seibel, P. G. Steinherz, H. N. Sather, et al., “Early Postinduction Intensification Therapy Improves Survival for Children and Adolescents With High‐risk Acute Lymphoblastic Leukemia: A Report From the Children's Oncology Group,” Blood 111, no. 5 (2008): 2548–2555.

Publication types

MeSH terms

LinkOut - more resources