DFCI 16-001, Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children andAdolescents


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This is a Harvard Dana Farber Cancer Institute treatment protocol for children and adolescents that are newly diagnosed with acute lymphoblastic leukemia. ALL is a cancer of the blood. 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 patients 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.

Are you Eligible? (Inclusion Criteria)

  • Subjects must be at least 1 year and up to 21 years of age at the time of study entry.
  • Patients must have a confirmed diagnosis of acute lymphoblastic leukemia.
  • Patients must have had no prior therapy before enrollment except for a short course of steroids, one dose of cytarabine, and/or emergent radiation therapy.
  • Patients must also meet all eligibility criteria as outlined in the study protocol.

Specialty Area(s)

Acute Lymphocytic leukemia, Childhood and Adolescent Cancers (Pediatric)

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032