Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

January 31, 2017

Study Completion Date

November 30, 2018

Conditions
Acute Lymphoblastic Leukemia
Interventions
DRUG

Everolimus

Orally, daily days 1-32 per assigned dose level

DRUG

Prednisone

40 mg/m2/day orally 3 x daily days 4-32

DRUG

Vincristine

1.5 mg/m2 IV daily on days 4, 11, 18, and 25

DRUG

PEG-Asparaginase

2,500 U/m2 IV 1 x daily on days 5 and 18

DRUG

Doxorubicin

30 mg/m2 IV on days 4 and 5

DRUG

Dexrazoxane

300 mg/m2 IV on days 4 and 5

Trial Locations (8)

12549

Columbia University Medical Center, New York

30322

Children's Healthcare of Atlanta, Atlanta

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

80045

Children's Hospital Colorado, Aurora

94143

UCSF, San Francisco

98105

Seattle Children's Hospital, Seattle

02115

Boston Children's Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Dana-Farber Cancer Institute

OTHER

NCT01523977 - Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL | Biotech Hunter | Biotech Hunter