Study on Treating Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Teens

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT03020030

This clinical trial is exploring a new approach to treating acute lymphoblastic leukemia (ALL) in children and adolescents. The study aims to improve treatment by using updated risk factors to determine the strength of chemotherapy and testing a new dosing method for the drug pegaspargase to reduce side effects while maintaining effectiveness.

Patient Parameters

Program Overview

Acute lymphoblastic leukemia (ALL) is a common type of cancer in children that affects blood cells called lymphocytes. These cancerous cells, known as lymphoblasts, crowd out healthy blood cells, making it hard for the body to fight infections. Without treatment, ALL is fatal, but most children can be cured with current therapies. The standard treatment involves about two years of chemotherapy, with the strength of treatment varying based on certain risk factors. This study is testing a new set of risk factors to better tailor treatment strength and is also exploring a new way to dose the chemotherapy drug pegaspargase, aiming to reduce side effects while still effectively treating the leukemia.

Description

In this study, researchers are using both traditional and new risk factors to decide how strong the treatment should be for children with ALL. Traditional risk factors include the child's age at diagnosis, white blood cell count, presence of leukemia in the spinal fluid, and certain genetic changes in the leukemia cells. A special test called MRD (Minimal Residual Disease) measures the amount of leukemia left after the first month of treatment. New risk factors include additional genetic changes and MRD levels after 2-3 months of treatment. The goal is to identify which children might benefit from stronger treatment to improve their chances of being cured, and which children can be treated with standard therapy to minimize side effects. The study also examines a new way to dose the drug pegaspargase, which is important for treating ALL but can cause side effects. Researchers will compare the standard dose with a new method that starts with a lower dose and adjusts based on blood levels of the drug. This approach aims to reduce side effects while maintaining effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of acute lymphoblastic leukemia (ALL) through bone marrow tests showing at least 25% lymphoblasts.
  • No prior therapy except for short courses of corticosteroids (up to 7 days) or a single dose of intrathecal cytarabine.
  • Age between 1 year and under 22 years.
  • Direct bilirubin level less than 1.4 mg/dL.
  • Parent or guardian must understand and sign a consent form.

Exclusion Criteria

  • Diagnosis of mature B-cell (Burkitt's) ALL or mixed phenotype acute leukemia.
  • Previous chemotherapy or radiotherapy for any cancer.
  • Previous treatment with certain anti-cancer drugs for any reason.
  • Currently taking investigational drugs.
  • Known HIV-positive status.
  • Uncontrolled illnesses, such as severe infections or heart problems.
  • Pregnant or breastfeeding women.
  • History of another cancer, unless treated with surgery only over 5 years ago.

Locations

FACILITYZIPCITYSTATE
Boston Children's Hospital02115BostonMassachusetts
Dana-Farber Cancer Institute02215BostonMassachusetts
Rutgers Cancer Institute of New Jersey08903New BrunswickNew Jersey
Roswell Park Cancer Institute14263BuffaloNew York
Columbia University Medical Center, Morgan Stanley Children's Hospital of New York-Presbyterian10032New YorkNew York
Montefiore Medical Center10467The BronxNew York
Hasbro Children's Hospital / Rhode Island Hospital02903ProvidenceRhode Island

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