Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

560

Participants

Timeline

Start Date

March 3, 2017

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2034

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

Trial Locations (9)

10032

Columbia University Medical Center, Morgan Stanley Children's Hospital of New York-Presbyterian, New York

10467

Montefiore Medical Center, The Bronx

14263

Roswell Park Cancer Institute, Buffalo

02115

Boston Children's Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

02903

Hasbro Children's Hospital / Rhode Island Hospital, Providence

Unknown

Hospital Sainte Justine, University of Montreal, Montreal

Centre Hospitalier U. de Quebec, Québec

All Listed Sponsors
collaborator

Servier

INDUSTRY

lead

Dana-Farber Cancer Institute

OTHER