Evaluation of the Efficacy of Ponatinib in Ph+ ALL in the Real-world
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto
About this trial
The goal of this retrospective observational study is to learn about the efficacy of ponatinib in Philadelphia-positive ALL (Ph+ ALL) patients in a real-world setting. The main goal of the study is to assess the rate of complete molecular response (CMR) induced by ponatinib in patients treated under the regulations of Law 648/96, outside clinical trials.
Patients who were treated with ponatinib as part of their regular medical care and completed the follow-up period will be included in the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is > 18 years old;
Patient was treated in first-line with ponatinib monotherapy or in association with chemotherapy or immunotherapy;
Patient received ponatinib under the regulations of Law 648/96;
- Patient is alive and have at least 18 months of retrospective observation available from the start of ponatinib treatment, OR
Disqualifiers
None
Trial population
Ph+ ALL patients treated with ponatinib, alone or in combination with other antileukaemic agents, under Law 648/96. According to AIFA guideline 425-2024, all patients who received ponatinib as first-line treatment under Law 648/96 are eligible for inclusion provided that, at the time of enrolment, they are alive and have at least 18 months of retrospective observation available from the start of ponatinib treatment, OR have died/lost to follow-up at any time after treatment initiation, regardless of the length of available follow-up.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
103 Participants
are grouped into 1 trial groupGroup A: Patients treated with ponatinib in first line
Trial outcomes
Primary outcomes
1
Efficacy of ponatinib in terms of complete molecular response (CMR) achievement
Rate of patients treated with ponatinb in first-line who achieve complete molecular response (CMR) after induction
Time frame
3 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: