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.

Conditions

• Acute Lymphoblastic Leukemia, Pediatric

Interventions

DRUG

Pegaspargase

Arm A: Standard/Fixed Dose Pegaspargase (2500 IU/m2 every 2 weeks) Arm B: Reduced Dose (PK-adjusted) Pegaspargase (Starting Dose: 2000 IU/m2) Arm X: Directly Assigned Standard Dose (2500 IU/m2): For all VHR and patients who decline randomization

DRUG

Erwinia asparaginase

Only for patients with Pegaspargase allergy or silent inactivation.

DRUG

Cyclophosphamide

Standard of Care

DRUG

CYTARABINE

Standard of Care

DRUG

DASATINIB

Standard of Care

DRUG

DEXAMETHASONE

Standard of Care

DRUG

Dexrazoxane

Standard of Care

DRUG

Doxorubicin

Standard of Care

DRUG

ETOPOSIDE

Standard of Care

DRUG

HYDROCORTISONE

Standard of Care

DRUG

LEUCOVORIN CALCIUM

Standard of Care

DRUG

MERCAPTOPURINE

Standard of Care

DRUG

METHOTREXATE

Standard of Care

DRUG

NELARABINE

Standard of Care

DRUG

Vincristine

Standard of Care

Sponsors & Collaborators

• Servier

  collaborator INDUSTRY

• Dana-Farber Cancer Institute

  lead OTHER

Principal Investigators

• Melissa Burns, MD · Dana-Farber Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-03

Primary Completion

2026-11-30

Completion

2034-11-30

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations