Phase II Study of Fludarabine, Cytarabine (ARA-C) and Erwinase IV in Patients With Relapsed or Refractory Hematologic Malignancies

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 31, 2018

Primary Completion Date

May 31, 2021

Study Completion Date

May 31, 2022

Conditions
Hematologic Malignancy
Interventions
DRUG

Fludarabine

"Induction Phase:~30 mg/m2 by vein over 15-30 minutes on Days 1 - 5 of a 28 day cycle.~Consolidation Phase:~30 mg/m2 by vein over 15-30 minutes on Days 1 - 4 of a 28 day cycle."

DRUG

Cytarabine

"Induction Phase:~2 grams/m2 by vein over approximately 2 hours on Days 1 - 5 of a 28 day cycle.~Consolidation Phase:~2 grams/m2 by vein over approximately 2 hours on Days 1 - 4 of a 28 day cycle."

DRUG

Erwinase

"Induction Phase:~25,000 Units/m2 by vein (or intramuscularly) over 90-120 minutes on Days 1 - 7 of a 28 day cycle.~Consolidation Phase:~25,000 Units/m2 by vein (or intramuscularly) over 90-120 minutes every other day on Days 1, 3, 5, 7, 9, 11, 13, 15 of a 28 day cycle."

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER