Status:
RECRUITING
Ponatinib Plus Chemotherapy in Acute Lymphoblastic Leukemia Patients
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Chemotherapy
Leukemia, Acute Lymphoblastic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ou...
Detailed Description
This is an interventional, phase II study, foreseeing a run-in phase for adult BCR/ABL1-like ALL patients. Thirty-two newly-diagnosed B-lineage ALL cases with a BCR/ABL1-like profile will be treated (...
Eligibility Criteria
Inclusion
- 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
- 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 enrollment,
- Congestive heart failure within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards,
- History of clinically significant (as determined by the treating physician) atrial arrhythmia,
- Any history of ventricular arrhythmia,
- Any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism.
- Uncontrolled hypertension (diastolic blood pressure \>90 mm Hg; systolic \>140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control.
- Taking medications that are known to be associated with torsades de pointes.
- Taking any medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib.
- Creatinine levels \> 2.5mg/dl or glomerular filtration rate (GFR) \< 20 ml/min or proteinuria \>3.5 g/day.
- Gastrointestinal (GI) function impairment, or a GI disease that may significantly alter the absorption of study drugs.
- Patients who are currently receiving treatment with any of the medications with potential to prolong QT interval (listed in Appendix F) if the medications cannot be either discontinued or switched to a different medication prior to starting study drug.
- Patients who have received any investigational drug ≤ 4 weeks.
- Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
- Patients who are pregnant or breast feeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs. prior to administration of Ponatinib). Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ two effective reliable methods of birth control throughout the study and for up to 12 months following discontinuation of study drugs.
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
- Patients unwilling or unable to comply with the protocol.
Key Trial Info
Start Date :
October 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05306301
Start Date
October 5 2022
End Date
July 1 2028
Last Update
February 7 2024
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
Ematologia con Unità di Trapianto
Avellino, AV, Italy, 83100
2
Ematologia Presidio Ospedaliero Tortora
Pagani, SA, Italy
3
Ematologia ASST Papa Giovanni XXIII
Bergamo, Italy
4
Ematologia AOU S.ORSOLA-MALPIGHI
Bologna, Italy