IMMUNOSTIM is a sub-study of the STIM trial approved by French health authorities (NCT00478985).9 Written informed consent was given in agreement with the Declaration of Helsinki. Imatinib was stopped after ≥3 years of therapy and ≥2 years of undetectable BCR-ABL1 transcripts. Stringent monitoring by RT-qPCR was performed after imatinib discontinuation to detect a molecular relapse.9 The assay sensitivity was ≥4.5 log. Consecutively detectable peripheral blood BCR-ABL1 transcripts showing a ≥1 log increase or loss of a major molecular response [BCR-ABL1/ABL1 internationally standardized (IS) ratio ≤0.1%] defined molecular relapse and triggered imatinib resumption. In IMMUNOSTIM, heparinized blood was collected at baseline, bimonthly for 6 months then every 6 months until 24 months unless imatinib was resumed. Healthy donors were recruited through the Paris Saint-Louis Blood Donation Center and gave informed consent. Experiments were performed in a centralized fashion, allowing ≤48 h from blood collection to processing.
Do you have any questions about this protocol?
Post your question to gather feedback from the community. We will also invite the authors of this article to respond.