Italian Treatment Free Remission Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Turin, Italy
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Patients who were diagnosed with accelerated or blastic phase CML will be excluded
Trial population
Patients with CP-CML who discontinued treatment with TKIs in Italy will be selected.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
800 Participants
are grouped into 3 trial groupsGroup A: Cohort 1
Group B: Cohort 2
Group C: Cohort 3
Trial outcomes
Primary outcomes
1
TFR rate at 1 year from discontinuation of TKIs
To assess the TFR rate at 1 year from discontinuation of TKIs
Time frame
1 yearSecondary outcomes
1
Secondary objectives
treatment-free duration (months); survival in MR4.5 (%); survival in MR3 (%); event-free survival (%); progression-free survival (%); deaths after treatment discontinuation (%); rate of achievement of MMR and DMR after treatment re-initiation (%)
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov