New Data Confirm Safety of Stopping Imatinib in Leukemia
AT THE ANNUAL CONGRESS OF THE EUROPEAN HEMATOLOGY ASSOCIATION
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.
