Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)

Phase 2 Terminated 15 enrolled Nantes University Hospital

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2006-11
Primary completion: 2011-07
Completion: 2011-11

Outcome

Outcome not reported

Stopped (Enrollment): “Difficulties of recruitment”

Publications

Chevallier P, Robillard N, Charbonnier A, Raffoux E, Maury S, Carras S, Chabrot C, Fohrer C, Bernard M, Blade JS, Etienne A, Talmant P, Delaunay J, Guillaume T, Mohty M, Bene MC, Ifrah N, Dombret H. Trastuzumab for treatment of refractory/relapsed HER2-positive adult B-ALL: results of a phase 2 GRAALL study. Blood. 2012 Mar 15;119(11):2474-7. doi: 10.1182/blood-2011-11-390781. Epub 2012 Jan 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trastuzumab	Monoclonal antibody	2 mg/kg	Intravenous