This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till progression. Response and HER2 expression are assessed each month by bone marrow aspirate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or until progression
Clermont-Ferrand University Hospital
Clermont-Ferrand, France
Mondor Hospital
Créteil, France
Grenoble Hospital
Grenoble, France
Institut Paoli Calmettes
Marseille, France
Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
Trastuzumab efficiency concerning transfusional needs
Overall survival
Leukemia free survival
cytogenetic response rate
Trastuzumab tolerance profile
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CHU
Nantes, France
St Louis Hospital
Paris, France
Rennes University Hospital
Rennes, France
Strasbourg University Hospital
Strasbourg, France