Ponatinib Plus Chemotherapy in Acute Lymphoblastic Leukemia Patients (NCT05306301) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ponatinib Plus Chemotherapy in Acute Lymphoblastic Leukemia Patients
Italy32 participantsStarted 2022-10-05
Plain-language summary
Acute lymphoblastic leukemia (ALL) is the most frequent cancer in children, decreases in adolescence and adulthood, and a second peak can be recorded starting from the 6th decade of life. While the outcome in children is excellent, in the adolescent/adult population, the prognosis, though improved over the decades, it is still unsatisfactory and novel biologically-driven approaches are urgently needed. In this setting, thanks to the introduction of genome wide technologies, it was possible to recognize specific subset of ALL. Among those, the BCR/ABL1-like ALL are of extreme importance, since they are characterized by an unfavourable outcome and, on the other hand, can benefit of a targeted treatment, in particular with the pan-tyrosine kinase inhibitor ponatinib.
The primary objective is to evaluate the clinical response - in terms of MRD negativity - in patients with a BCR/ABL1-like profile, according to the BCR/ABL1-like predictor tool, treated with Ponatinib in combination with chemotherapy.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-65 years.
* De novo Ph+-like ALL, as defined by the BCR/ABL1-like predictor (13).
* WHO score ≤2.
* Adequate liver function, as defined by the following criteria: total serum bilirubin ≤1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, alanine aminotransferase (ALT) ≤2.5 × ULN or ≤2.5 x ULN or leukemia related.
* Adequate pancreatic function as defined by serum lipase and amylase ≤1.5 × ULN or leukemia related.
* No history of dyslipidemia, thrombotic events or cardiac disease.
* For females of childbearing potential, a negative pregnancy test must be documented.
* Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from enrollment through 12 months after the end of treatment.
* Signed informed consent, according to ICH/EU/GCP and national regulation.
Exclusion Criteria:
* WHO performance status \>2.
* Active HBV or HCV hepatitis, or AST/ALT \> 2.5 x ULN and bilirubin \> 1.5 x ULN.
* History of acute pancreatitis within 1 year of study or history of chronic pancreatitis.
* History of alcohol abuse.
* Ongoing or active infections.
* Uncontrolled hypertriglyceridemia (triglycerides \>450 mg/dL).
* Clinically significant, uncontrolled or active cardiovascular disease, specifically including, but not restricted to:
* Any history of myocardial infarction, stroke, or revascularization, unstable angina or transient ischemic attack within 6 months prior to enrollmen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MRD Negativity Rate after 3 cycles (TP2) in patients with BCR/ABL1-like ALL treated with a Ponatinib plus chemotherapy approach
Timeframe: 3 months
Trial details
NCT IDNCT05306301
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto