Evaluation of the Efficacy of Ponatinib in Ph+ ALL in the Real-world

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.

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Key information

Conditions

Acute Lymphobkastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This is a non-interventional, multicenter, strictly retrospective study including 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

has died/lost to follow-up at any time after treatment initiation, regardless of the length of available follow-up;
Signed informed consent, if applicable.

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Efficacy of ponatinib in terms of complete molecular response (CMR) achievement

Time frame: 3 months

Rate of patients treated with ponatinb in first-line who achieve complete molecular response (CMR) after induction

Study contacts

Contact information is provided by the study sponsor or research team.

Enrico Crea

CONTACT

[email protected]

0039 0670390514

Paola Fazi

CONTACT

[email protected]

0039 0670390528

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

Retrospective, Observational, Study on the Evaluation of the Real-world Outcome of Philadelphia-positive Acute Lymphoblastic Leukaemia Patients Treated With Ponatinib as First-line Treatment Under the Italian Law 648/96 (PONA4ALL Ph+)

Acronym: PONA4ALL Ph+

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jan 21, 2026
Registry last updated: Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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