The primary aim is to estimate the persistence of molecular remission in CML after stopping treatment with available TKIs. EURO-SKI will measure MMR 4 (BCR-ABL of 0.01% or less) and MMR (BCR-ABL of 0.1% or less). Patients will need to achieve MMR 4 for at least 1 year before they can stop TKI therapy, and will have reached the end point if they lose MMR and the BCR-ABL transcript level rises over the 0.1% threshold.
"We are using MMR, which is one log higher than MMR 4 used in the STIM study," Dr. Saussele said. "This is because the STIM study showed that a lot of patients are between MMR4 and MMR."
The estimated date for completion of the trial is June 2017, with the first data available from the trial expected in roughly 3 years’ time.
The CML-8 study was conducted by the Australasian Leukemia and Lymphoma Group with funding from Novartis. Dr. Ross has received research funding and honoraria from Novartis. Dr. Saussele had no disclosures.