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Clinical Trials in Italy / NCT04475731
Active, not recruiting Phase 2

Ponatinib in Adult Ph+ ALL Patients With MRD Positivity or Hematological Relapse

NCT04475731 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2021-05-04
Last updated
2024-10-22

Condition(s) studied

Philadelphia-Positive ALLAcute Lymphoblastic Leukemia, in Relapse

Investigational drug(s) / intervention(s)

Ponatinib →

Ponatinib: Ponatinib 45 mg/day x 4 weeks x 3 courses. +/- chemotherapy: * vincristine or * L-VAMP (leucovorin, vincristine, aracytin, methotrexate, prednisone)

Study 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 extra-hematologic relapse and in the few patients who never achieved an hematologic remission after whatever prior treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Age ≥18 years old with no upper age limit. 3. 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. 4. Adequate pancreatic function as defined by the following criterion: \- serum lipase and amylase ≤1.5 × ULN. 5. For females of childbearing potential, a negative pregnancy test must be documented prior to enrollment. 6. 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. 7. Signed written informed consent according to ICH/EU/GCP and national local laws. Exclusion Criteria: 1. WHO performance status ≤ 50% (Karnofsky) or ≥ 3 (ECOG). 2. Uncontrolled active HBV or HCV hepatitis, or AST/ALT ≥ 2.5 x ULN and bilirubine ≥ 1.5 x ULN not due to the disease. 3. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis. 4. History of alcohol abuse. 5. Ongoing or active uncontrolled infections. 6. Uncontrolled hypertriglyceridemia (triglycerides \>450 mg/dL). 7. 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. 8. Taking medications that are known to be associated with Torsades de Pointes. 9. 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. 10. Creatinine level \>2.5mg/dl or glomerular filtration rate (GFR) \<20 ml/min or proteinuria \>3.5 g/day. 11. 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.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica Ancona Italy
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
Ao Di Rilievo Nazionale E Di Alta Specialità "San Giuseppe Moscati" - Avellino - Uoc Ematologia Con Unità Di Trapianto Avellino Italy
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto Bari Italy
Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia Bergamo Italy
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia Bologna Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia Brescia Italy
Aso S. Croce E Carle - Cuneo - Sc Ematologia Cuneo Italy
Aou Careggi - Firenze - Sod Ematologia Florence Italy
Aou Policlinico "G. Martino" - Messina - Uoc Ematologia Messina Italy
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia Mestre Italy
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia Milan Italy
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia Milan Italy
Aou Federico Ii - Napoli - Uoc Ematologia Naples Italy
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo Perugia Italy
Ao Ospedali Riuniti Marche Nord - Ospedale San Salvatore - Pesaro - Uoc Ematologia E Centro Trapianti Pesaro Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia Roma Italy
Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche Salerno Italy
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia San Giovanni Rotondo Italy
Aou Senese - Uoc Ematologia E Trapianti Siena Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2 Torino Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia Verona Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04475731 on ClinicalTrials.gov ↗ ← All trials in Italy