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 range18 Years – 65 Years
SexALL
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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…
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