Status:
ACTIVE_NOT_RECRUITING
Ponatinib in Adult Ph+ ALL Patients With MRD Positivity or Hematological Relapse
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Philadelphia-Positive ALL
Acute Lymphoblastic Leukemia, in Relapse
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II interventional trial to evaluate if the use of ponatinib, with or without chemotherapy, can induce a molecular remission in MRD-positive patients, in patients in hematologic and ext...
Detailed Description
This is a phase II interventional multicenter study for adult patients with Ph+ALL who: * Are MRD+ (i.e. BCR-ABL1/ABL1 \>0.01) (or loose their molecular response) after whichever kind of previous tre...
Eligibility Criteria
Inclusion
- Ph+ ALL patients with evidence of MRD disease or in hematologic and extra-hematologic relapse/refractoriness after any previous treatment, will be considered eligible to enter the study.
- Age ≥18 years old with no upper age limit.
- Adequate hepatic 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
- aspartate aminotransferase (AST) ≤2.5 × ULN.
- Adequate pancreatic function as defined by the following criterion:
- \- serum lipase and amylase ≤1.5 × ULN.
- For females of childbearing potential, a negative pregnancy test must be documented prior to enrollment.
- Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from enrollment through 4 months after the end of treatment.
- Signed written informed consent according to ICH/EU/GCP and national local laws.
Exclusion
- WHO performance status ≤ 50% (Karnofsky) or ≥ 3 (ECOG).
- Uncontrolled active HBV or HCV hepatitis, or AST/ALT ≥ 2.5 x ULN and bilirubine ≥ 1.5 x ULN not due to the disease.
- History of acute pancreatitis within 1 year of study or history of chronic pancreatitis.
- History of alcohol abuse.
- Ongoing or active uncontrolled 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 within 6 months prior to enrollment
- 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 level \>2.5mg/dl or glomerular filtration rate (GFR) \<20 ml/min or proteinuria \>3.5 g/day.
- Patients who are currently receiving treatment with any of the medications listed in Appendix E if the medications cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix E have the potential to prolong QT.
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04475731
Start Date
May 4 2021
End Date
November 1 2024
Last Update
October 22 2024
Active Locations (22)
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1
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
Ancona, Italy
2
Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
Ascoli Piceno, Italy
3
Ao Di Rilievo Nazionale E Di Alta Specialità "San Giuseppe Moscati" - Avellino - Uoc Ematologia Con Unità Di Trapianto
Avellino, Italy
4
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, Italy