Last updated on May 2019

ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission

Brief description of study

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).

Detailed Study Description

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

Clinical Study Identifier: NCT03117816

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