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Clinical Trials in Italy / NCT04769947
Recruiting Observational

Italian Treatment Free Remission Registry

NCT04769947 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Turin, Italy
Phase
Observational
Started
2021-08-09
Last updated
2021-11-18

Condition(s) studied

Treatment Free RemissionChronic Myeloid Leukemia

Study 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 the series of Italian patients with Philadelphia-positive, chronic phase CML (CP-CML) who discontinue TKIs in an off-protocol setting. As safety concerns may arise for patients receiving long-term treatments, and due to the growing number of patients discontinuing TKIs in clinical practice, the study aim to collect all available data regarding feasibility and freedom from progression of the cohort of patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Criteria: * Patients who were diagnosed with accelerated or blastic phase CML will be excluded

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Division of Hematology-AO Mauriziano Hospital, University of Turin Turin Italy Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04769947 on ClinicalTrials.gov ↗ ← All trials in Italy