Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+
NCT01354457 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2014-06-25
Summary
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.
Conditions
Interventions
- DRUG
-
Epratuzumab and 90Y-Epratuzumab
Sequential injections of each product with an escalating dose for radiolabeled Epratuzumab between patients
Sponsors & Collaborators
-
Nantes University Hospital
lead OTHER
Principal Investigators
-
Chevallier Patrice, MD · Nantes University Hospital
-
Kraeber-Bodere Françoise, MD · Nantes University Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2016-06-30
- Completion
- 2016-06-30
Countries
- France
Study Locations
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