Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

790

Participants

Timeline

Start Date

March 29, 2017

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2028

Conditions
Acute Lymphoblastic LeukemiaAcute Lymphoblastic Lymphoma
Interventions
DRUG

Prednisone

Given orally (PO).

DRUG

Vincristine

Given intravenously (IV).

DRUG

Daunorubicin

Given IV.

DRUG

Pegaspargase

Given IV or intramuscularly (IM) .

DRUG

Erwinase®

To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV or intramuscularly (IM).

DRUG

Cyclophosphamide

Given IV.

DRUG

Cytarabine

Given IV or by subcutaneous injection (SQ).

DRUG

Mercaptopurine

Given PO.

DRUG

Dasatinib

Given PO.

DRUG

Methotrexate

Given IV.

DRUG

Blinatumomab

Given IV.

DRUG

Ruxolitinib

Given PO.

DRUG

Bortezomib

Given IV or subcutaneously (SQ).

DRUG

Dexamethasone

Given PO.

DRUG

Doxorubicin

Given IV.

DRUG

Etoposide

Given IV.

DRUG

Clofarabine

Given IV.

DRUG

Vorinostat

Given PO.

DRUG

Idarubicin

Given IV.

DRUG

Nelarabine

Given IV.

DRUG

Thioguanine

Participants with mercaptopurine-related pancreatitis. Given PO.

DRUG

Asparaginase Erwinia chrysanthemi (recombinant)-rywn

To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given intramuscularly (IM).

DRUG

Calaspargase Pegol

To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV.

Trial Locations (8)

3052

The Royal Children's Hospital Melbourne, Parkville

28204

St. Jude Affiliate Clinic - Novant Health Hemby Children's Hospital, Charlotte

38105

St. Jude Children's Research Hospital, Memphis

48201

Children's Hospital of Michigan, Detroit

61637

Children's Hospital of Illinois at OSF-Saint Francis Medical Center (St. Jude Midwest Affiliate - Peoria), Peoria

76104

Cook Children's Medical Center, Fort Worth

92123

Rady Children's Hospital San Diego, San Diego

94305

Lucile Packard Children's Hospital Stanford University, Palo Alto

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Incyte Corporation

INDUSTRY

collaborator

Amgen

INDUSTRY

collaborator

Servier

INDUSTRY

lead

St. Jude Children's Research Hospital

OTHER

NCT03117751 - Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma | Biotech Hunter | Biotech Hunter