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Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

StatusActive, Not Recruiting
PhasePhase 3
Started2017-03-03
View on ClinicalTrials.gov ↗

Amendment history

2026-07-15
3 amendments v16-v18
3 re-verifications since 2025-07-01, no change to tracked fields
2025-01-02
Study Status v15
Primary completion date2024-11→2026-11-30
2024-08-14
Study Status, Sponsor/Collaborators, Contacts/Locations v14
Re-verified, no change to tracked fields
2024-04-30
Study Status v13
Completion date2028-11→2034-11
2023-11-07
3 amendments v10-v12
3 re-verifications since 2023-05-01, no change to tracked fields
Show 9 earlier versions
2022-11-10
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2022-12→2024-11
Completion date2026-12→2028-11
Study sitesdetails revised at 9 of 9 sites
2022-05-31
Study Status, Arms and Interventions v8
Re-verified, no change to tracked fields
2022-01-11
Study Status, Study Design v7
Enrollment target480→560
2021-09-14
Study Status v6
Re-verified, no change to tracked fields
2020-09-05
Study Status, Study Design v5
Enrollment target400→480
2020-01-03
Study Status v4
Primary completion date2021-12→2022-12
2019-05-23
Study Status, Sponsor/Collaborators, Contacts/Locations v3
Study sites8→9
Collaborators1 entry, revised
ShireServier
2018-07-31
Study Status, Contacts/Locations v2
Study sites5→8
2017-07-25
Not Yet Recruiting→Recruiting Study Status, Oversight, Arms and Interventions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2021-05→2021-12
Completion date2026-01→2026-12
Start date2017-01→2017-03-03
Study sites2→5
2017-01-11
Original filing
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.
Trial Details
NCT Number NCT03020030
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Servier
Conditions Acute Lymphoblastic Leukemia, Pediatric
Enrollment 560 participants
Start Date 2017-03-03
Primary Completion 2026-11-30 (estimated)
Study Completion 2034-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-16