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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 (RIT 90YEpra)
The purpose of this study is to determine whether fractionated RIT with Epratuzumab and radiolabeled Epratuzumab are effective in the treatment of relapsing or refractory ALL.
Details
| Lead sponsor | Nantes University Hospital |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 21 |
| Start date | 2010-11 |
| Completion | 2016-06 |
Conditions
- Acute Lymphoblastic Leukemia
Interventions
- Epratuzumab and 90Y-Epratuzumab
Primary outcomes
- Determination of MTD by evaluation of hematological and non hematoligical toxicity
The primary endpoint is to evaluate the incidence of dose limiting toxicities (DLT) in order to determine the maximal tolerated dose (MTD) in a dose escalating study design
Countries
France