Leukaemia, Myelocytic, Acute Clinical Trial
Official title:
Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic as Post-consolidation Therapy in Adult Patients With Acute Myeloid Leukemia
This study is being done to evaluate the safety of a WT1 Antigen-Specific Cancer Immunotherapeutic (WT1 ASCI) as post-consolidation therapy in adult patients with WT1-positive Acute Myeloid Leukemia in first complete remission. It will also be analyzed to what extent this treatment induces an immune response, specific to the malignancy.
In this study, patients were to receive a maximum of 24 doses of WT1 ASCI according four
cycles over a period of four years.
This protocol summary has been updated according to the Protocol Amendment 6 (dated 10 Sept
2014).
There will no longer be an active follow-up of patients after discontinuation or completion
of the treatment. The study will end 30 days after the last dose will be administered, so the
patients will not be further exposed to unnecessary study related procedures.. In addition,
no more biological samples will be collected for protocol research purposes. For each
biological sample already collected in the scope of this study and not tested yet, testing
will not be performed by default, except if a scientific rationale remains relevant. Blood
sampling for safety monitoring as per protocol will continue.
;
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