Clinical Trial Results:
A Phase III, multicenter, randomized controlled study to compare safety and efficacy of a haploidentical HSCT and adjunctive treatment with ATIR101, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells, versus a haploidentical HSCT with post-transplant cyclophosphamide in patients with a hematologic malignancy
Summary
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EudraCT number |
2016-004672-21 |
Trial protocol |
BE GB DE ES PT NL HR FR IT |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Apr 2022
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First version publication date |
01 Apr 2022
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Other versions |
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Summary report(s) |
Synopsis abbreviated CSR (active phase study) Synopsis addendum CSR long term safety follow-up_21FEB2022 |
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.