A randomized, open-label assessor blinded, multi-center, controlled phase II Trial to
evaluate the efficacy of AOP2014 administered bi-weekly subcutaneously (s.c.) in preventing
molecular relapse (loss of MMR) in CML patients, who discontinue ABL tyrosine kinase
inhibitor therapy (TKI) in deep molecular remission of MR4 or better (MR4.5, or MR5).
Four hypotheses are tested in hierarchical order. To avoid inflation of type 1 error (false
rejection of a null hypothesis), further confirmatory testing has to be stopped as soon as a
null hypothesis could not be rejected.
All four hypotheses are tested at significance level 0.05. Null hypotheses 1, 2, and 4 deal
with probabilities of molecular relapse-free survival 7, 13, and 25 months after
randomisation, respectively; arms A and B are compared with the uncorrected chi-square test.
Null hypothesis 3 investigates molecular relapse-free survival as a time-to-event variable;
the two arms are compared with the log-rank test
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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