Status:
RECRUITING
Italian Treatment Free Remission Registry
Lead Sponsor:
University of Turin, Italy
Conditions:
Treatment Free Remission
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
The investigator propose an extension of the previous National, multicentric study, promoting an observational registry, both retrospective and prospective, in order to expand and further characterize...
Detailed Description
This is an observational, retrospective and prospective study of CP-CML patients who discontinue TKIs in Italy. The study will not imply additional costs for the participating centers. Data already pr...
Eligibility Criteria
Inclusion
- Patients with CP-CML, treated with TKI monotherapy or TKI in association with other drugs (such as interferon, BCR-ABL1 peptidic vaccine and others)
- Treatment with TKI discontinued for any reason
- Deep Molecular Response (DMR), defined as MR4 (BCR-ABL1 ratio ≤ 0.01% with at least 10,000 ABL1 copies), or MR4.5 (BCR-ABL1 ratio ≤ 0.0032% with at least 32,000 ABL1 copies), or MR5 (BCR-ABL1 ratio ≤ 0.001% with at least 100,000 ABL1 copies), confirmed at least three times before TKI discontinuation. In patients who discontinued TKIs before the establishment of molecular standardization, DMR will be defined as a level of BCR-ABL1 transcript undetectable by qPCR or by qualitative PCR, confirmed in at least two controls.
- Participant is willing and able to give informed consent for participation in the study Data regarding patients discontinuing in less than DMR (as defined above) will be collected and analysed separately.
Exclusion
- Patients who were diagnosed with accelerated or blastic phase CML will be excluded
Key Trial Info
Start Date :
August 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 8 2030
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04769947
Start Date
August 9 2021
End Date
February 8 2030
Last Update
November 18 2021
Active Locations (1)
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1
Division of Hematology-AO Mauriziano Hospital, University of Turin
Turin, Italy, 10128