CML, Relapsed Clinical Trial
Official title:
Persistence Of Major Molecular Remission In Chronic Myeloid Leukemia After A Second Stop Of Tki Treatment In Patients Who Failed An Initial Stop Attempt: A Multicenter Prospective Trial
This study will enroll CML patients who have failed a first TKI stopping attempt. After failure and at least a year of TKI treatment, patients will proceed to dasatinib treatment for another 2 years. If MR4 or better is re-achieved and maintained for at least one year, patients will be eligible for a second stop. After verification of MR4, TKI treatment will be stopped and patients followed in the same manner as after first stop. If MMR is lost (BCR-ABL >0.1% (IS)), TKI treatment will once again be restarted.
The DASTOP2 study aims to retreat patients who relapse in the Euro-SKI study (or who stopped
TKI treatment outside trials but according to EURO-SKI procedures), with TKI for at least
another 3 years, out of last two years with dasatinib. If MR4 or better is re-achieved and
maintained for at least one year, patients will be eligible for a second stop. After
verification of MR4, TKI treatment will be stopped and patients followed in the same manner
as after first stop. If MMR is lost (BCR-ABL >0.1% (IS)), TKI treatment will once again be
restarted.
Patients exhibiting hematological relapse after first stop attempt will not be offered a
second stop within this study. The same applies to patients in whom TKI was restarted
prematurely (without loss of MMR).
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