Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)
Phase 2
Terminated
- Conditions
- Relapsed/Refractory Leukemia
- Registration Number
- NCT00724360
- Lead Sponsor
- Nantes University Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- age > 18 years
- B-ALL in relapse
- refractory B-ALL-performance status of 0-2 on the Eastern Cooperative Oncology Group scale
- adequate hepatic and renal functions (AST or ALT <= 5 times the upper limit of normal creatinine < 2 times the upper limit of normal)
- > 20% blasts in bone marrow,
- > 30% of bone marrow blast population HER2 positive as assessed by immunophenotyping
Exclusion Criteria
- Previous treatment by trastuzumab
- FEVG < 50%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
- Secondary Outcome Measures
Name Time Method Trastuzumab tolerance profile Trastuzumab efficiency concerning transfusional needs Overall survival Leukemia free survival cytogenetic response rate
Trial Locations
- Locations (8)
Grenoble Hospital
🇫🇷Grenoble, France
CHU
🇫🇷Nantes, France
Clermont-Ferrand University Hospital
🇫🇷Clermont-Ferrand, France
Mondor Hospital
🇫🇷Créteil, France
Institut Paoli Calmettes
🇫🇷Marseille, France
Rennes University Hospital
🇫🇷Rennes, France
St Louis Hospital
🇫🇷Paris, France
Strasbourg University Hospital
🇫🇷Strasbourg, France