NCT04769947 Italian Treatment Free Remission Registry
| NCT ID | NCT04769947 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Turin, Italy |
| Condition | Treatment Free Remission |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2021-08-09 |
| Primary Completion | 2022-07-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2021-08-09 with a primary completion date of 2022-07-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04769947 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Treatment Free Remission. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04769947 currently recruiting?
Yes, NCT04769947 is actively recruiting participants. Contact the research team at carmen.fava@unito.it for enrollment information.
Where is the NCT04769947 trial being conducted?
This trial is being conducted at Turin, Italy.
Who is sponsoring the NCT04769947 clinical trial?
NCT04769947 is sponsored by University of Turin, Italy. The trial plans to enroll 800 participants.