Clinical Trial Results:
An open-labeled, randomized, two-dose, parallel group trial of ofatumumab, a fully human monoclonal anti-CD20 antibody, in combination with fludarabine and cyclophosphamide, in patients with previously untreated B-cell Chronic Lymphocytic Leukemia
Summary
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EudraCT number |
2007-000243-10 |
Trial protocol |
DE LT CZ GB |
Global completion date |
21 May 2013
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Jul 2016
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First version publication date |
07 Jul 2016
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Other versions |
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Summary report(s) |
111774-FDAAA-Result-Summary |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.