Status:
TERMINATED
Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)
Lead Sponsor:
Nantes University Hospital
Conditions:
Relapsed/Refractory Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 d...
Eligibility Criteria
Inclusion
- 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
- Previous treatment by trastuzumab
- FEVG \< 50%
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00724360
Start Date
November 1 2006
End Date
November 1 2011
Last Update
October 7 2013
Active Locations (8)
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1
Clermont-Ferrand University Hospital
Clermont-Ferrand, France, 63003
2
Mondor Hospital
Créteil, France, 94000
3
Grenoble Hospital
Grenoble, France, 38043
4
Institut Paoli Calmettes
Marseille, France, 13273