Phase I Study of mPEG-R-Crisantaspase Given IV

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Hematologic Malignancies
Interventions
BIOLOGICAL

mPEG-r-crisantaspase

IV infusion over 60 minutes of mPEG-r-crisantaspase given once every two or four weeks for two administrations. Based on non-clinical data, 500IU/m2 has been selected as the starting dose. Dose selection will proceed based upon safety and pharmacokinetic data but escalation will not exceed 100%

Trial Locations (5)

31052

Institut Claudius Regaud, Toulouse

69495

Hospices Civils de Lyon, Pierre-Bénite

76038

Centre Henri Becquerel, Rouen

94010

Hôpital Henri Mondor, Créteil

Unknown

Hôpitaux du CHU de Nantes, Nantes

Sponsors
All Listed Sponsors
collaborator

EUSA SAS

UNKNOWN

collaborator

The Lymphoma Academic Research Organisation

OTHER

lead

Jazz Pharmaceuticals

INDUSTRY