A Pilot Study of Recombinant Human Arginase 1 (rhArg1) in Patients With Relapsed or Refractory Leukemia or Lymphoma

PHASE1TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2013

Conditions
LeukemiaLymphoma
Interventions
DRUG

Recombinant human arginase 1 Peg5000

Patients will receive weekly IV infusions of PEG-BCT-100, until evidence of disease progression, intolerable adverse events, or withdrawal of patient consent. For safety sake, each subject will receive an induction dose of PEG-BCT-100 500 U/kg and 1000 U/kg at week -2 and week -1, respectively. The study dose of PEG-BCT-100 1600 U/kg will be initiated at week 1 (Day1). Each escalation of dose level will be determined by the investigator according to each subject's tolerability and criteria for treatment discontinuation.

Trial Locations (1)

Unknown

Department of Paediatrics and Adolescent Medicine, The University of Hong Kong, Hong Kong

All Listed Sponsors
collaborator

The University of Hong Kong

OTHER

lead

Bio-Cancer Treatment International Limited

INDUSTRY

NCT01551628 - A Pilot Study of Recombinant Human Arginase 1 (rhArg1) in Patients With Relapsed or Refractory Leukemia or Lymphoma | Biotech Hunter | Biotech Hunter