NCT02518750View on ClinicalTrials.gov

Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

November 23, 2016

Primary Completion Date

March 11, 2018

Study Completion Date

March 11, 2018

Conditions
Acute Lymphoblastic LeukemiaLymphoma, Non-Hodgkin'sLeukemia, T-CellLeukemia, B-Cell
Interventions
DRUG

Dexamethasone

Given orally (PO).

DRUG

Panobinostat

Given PO.

DRUG

Liposomal vincristine

For intravenous (IV) use only.

DRUG

Mitoxantrone

Given IV.

DRUG

Peg-asparaginase

"Given IV or intramuscularly (IM).~In case of allergy or intolerance to Peg-asparaginase, Erwinia L-asparaginase (Erwinase®) will be used. Erwinia L-asparaginase is given by either IV or IM injection."

DRUG

Bortezomib

Given by IV push over 3 to 5 seconds. For IV use only.

DRUG

Intrathecal Triples

Given IT as ITMHA.

DRUG

High-dose methotrexate

Given intrathecally (IT) or IV.

DRUG

6-Mercaptopurine

Given PO at consistent time each day.

DRUG

High-dose cytarabine

Given IT or IV.

DRUG

Nelarabine

Given IV

DRUG

Cyclophosphamide

Given IV.

DRUG

Etoposide

"Given IV.~In case of etoposide reactions, IV etoposide phosphate (Etopophos®) will be used."

DRUG

Clofarabine

"Given IV.~Clofarabine will be given instead of nelarabine for patients with B-lymphoblastic leukemia and lymphoma in stratum II."

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

Sponsors

Collaborators (1)

Novartis Pharmaceuticals
All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

collaborator

Spectrum Pharmaceuticals, Inc

INDUSTRY

lead

St. Jude Children's Research Hospital

OTHER