Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)
NCT ID: NCT00724360
Last Updated: 2013-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
15 participants
INTERVENTIONAL
2006-11-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Herceptin (trastuzumab)
Administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or until progression
Eligibility Criteria
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Inclusion Criteria
* 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
* FEVG \< 50%
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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Clermont-Ferrand University Hospital
Clermont-Ferrand, , France
Mondor Hospital
Créteil, , France
Grenoble Hospital
Grenoble, , France
Institut Paoli Calmettes
Marseille, , France
CHU
Nantes, , France
St Louis Hospital
Paris, , France
Rennes University Hospital
Rennes, , France
Strasbourg University Hospital
Strasbourg, , France
Countries
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References
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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.
Other Identifiers
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BRD04/2-T
Identifier Type: -
Identifier Source: org_study_id