Evaluation of the Efficacy and Tolerance of Fractionated Radio-immunotherapy With 90Y-Epratuzumab (90Y-hLL2) for Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of MTD by evaluation of hematological and non hematoligical toxicity
The primary endpoint is to evaluate the incidence of dose limiting toxicities (DLT) after J30 and J37 in order to determine the maximal tolerated dose (MTD) in a dose escalating study design
Yes
Chevallier Patrice, MD
Principal Investigator
CHU Nantes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
BRD 08/12-H
NCT01354457
November 2010
November 2012
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