A Dose Escalation Phase I Study of Asparec®(mPEG-R-Crisantaspase) Administered as Intravenous (IV) Infusion in Patients With Relapsed or Refractory Hematological Malignancies
Planned sample size: Up to 36 evaluable subjects will be enrolled in the study: a maximum
of 30 subjects for the dose escalation phase and up to a maximum of 12 patients in the
Inclusion criteria consists of:
Patients with any relapsed or refractory hematological malignancy, for which standard
curative or life prolonging treatment does not exist, or is no longer effective or
For the following hematological malignancies, patients must have received at least: Low
rade NHL: 3 prior lines of therapy, ALL, aggressive NHL and other hematological
malignancies: 2 prior lines of therapy, Aged 18 to 50 years and ECOG performance status of
1, 1 or 2.
All patients will be treated with Asparec once every two to four weeks for two IV
administrations infused in 60 minutes. Patients without Disease Progression may receive
additional administrations, each administration starting at least 14 days but no later than
28 days after the previous Asparec administration.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
To determine the Maximum Tolerated Dose following one single dose of mPEG-r-Crisantaspase when administered in a population of patients with relapsed or refractory hematological malignancies, as measured by Dose Limiting Toxicities.
Pr Gilles Salles, MD
Centre Hospitalier Lyon Sud -Chemin du Grand Revoyet
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)