Status:
UNKNOWN
Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Leukemia, Myeloid, Chronic-Phase
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate the proportion of subjects with chronic myeloid leukemia chronic phase that sustain major molecular response after imatinib discontinuation. To be eligible for this protocol, ...
Detailed Description
Patients will be followed for 2 years, with molecular monitoring, every month in the first year and then every 2 months. Imatinib will be restarted if the major molecular response (RM3log) is lost dur...
Eligibility Criteria
Inclusion
- Chronic myeloid leukemia chronic-phase, defined by the World Health Organization criteria
- Treatment with imatinib for at least 36 months
- BCR-ABL levels below 0,01% (IS) or MR4log in the last 12 months
Exclusion
- Previous allogeneic stem cell transplantation
- Previous treatment with dasatinib, nilotinib, bosutinib or ponatinib
- Imatinib dose escalation at any time, due to loss or inadequate response
- BCR-ABL mutation
- IS: International Scale
- MR4log: molecular response of 4log or \<0,1% (IS)
Key Trial Info
Start Date :
December 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03239886
Start Date
December 15 2016
End Date
January 31 2020
Last Update
March 23 2018
Active Locations (1)
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1
Centro de Pesquisa Clínica da Hematologia do HCFMUSP
São Paulo, São Paulo, Brazil