Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

Summary

Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in children. The cancer comes from a cell in the blood called a lymphocyte. Normal lymphocytes are produced in the bone marrow (along with other blood cells) and help fight infections. In ALL, the cancerous lymphocytes are called lymphoblasts. They do not help fight infection and crowd out the normal blood cells in the bone marrow so that the body cannot make enough normal blood cells. ALL is always fatal if it is not treated. With current treatments, most children and adolescents with this disease will be cured. The standard treatment for ALL involves about 2 years of chemotherapy. The drugs that are used, and the doses of the drugs, are similar but not identical for all children and adolescents with ALL. Some children and adolescents receive stronger treatment, especially during the first several months. A number of factors are used to decide how strong the treatment should be to give the best chance for cure. These factors are called "risk factors". This trial is studying the use of a new, updated set of risk factors to decide how strong the treatment will be. The study also will test a new way of dosing a chemotherapy drug called pegaspargase (which is part of the standard treatment for ALL) based on checking levels of the drug in the blood and adjusting the dose based on the levels.

Timeline

Start

2017-03-03

Primary completion

2026-11-30

Completion

2034-11

Publications

• Willekens J, Ramjan S, Sands SA, Park Y, K C N, Burns MA, Welch JJG, Kahn J, Kelly KM, Tran TH, Michon B, Gennarini L, Place A, Silverman LB, Cole PD. CSF metabolomic signature during therapy for childhood acute lymphoblastic leukemia predicts subsequent working memory impairment. Mol Med. 2025 Dec 30;32(1):12. doi: 10.1186/s10020-025-01414-z.
• Park Y, K C N, Willekens J, Patel C, Savage BA, Lin H, Paneque A, Daly R, Thrope A, Burns MA, Welch JJG, Kahn JM, Kelly KM, Tran TH, Michon B, Gennarini L, Silverman LB, Sands SA, Cole PD. Treatment-Related Changes in Cerebrospinal Fluid Markers of Oxidative Stress and Neurodegeneration during Therapy for Childhood Acute Lymphoblastic Leukemia. Cancer Epidemiol Biomarkers Prev. 2025 Nov 3;34(11):2015-2024. doi: 10.1158/1055-9965.EPI-25-1058.
• Tran TH, Langlois S, Meloche C, Caron M, Saint-Onge P, Rouette A, Bataille AR, Jimenez-Cortes C, Sontag T, Bittencourt H, Laverdiere C, Lavallee VP, Leclerc JM, Cole PD, Gennarini LM, Kahn JM, Kelly KM, Michon B, Santiago R, Stevenson KE, Welch JJG, Schroeder KM, Koch V, Cellot S, Silverman LB, Sinnett D. Whole-transcriptome analysis in acute lymphoblastic leukemia: a report from the DFCI ALL Consortium Protocol 16-001. Blood Adv. 2022 Feb 22;6(4):1329-1341. doi: 10.1182/bloodadvances.2021005634.

Drugs

Indications