BridgeMD
The aim of the study is to evaluate the efficacy of Ponatinib, either alone or in combination with chemotherapy, in inducing remission in patients: MRD positive (persistent or relapsed), patients after haematological and extra-haematological relapse and patients who do not have never achieved remission after any previous treatment.
EU CTIS ID: 2024-516868-28-00
What this study is testing
The primary objective of this study is to evaluate the rate of patients obtaining a MRD negativity/MRD reduction following treatment with either ponatinib alone or in combination with systemic chemotherapy after 3 months of treatment. Since both MRD+ and hematologically and extra-hematologically relapsed/refractory patients will be considered, the primary objective will be analyzed separately in the two groups of MRD+ and hematologically and extra-hematologically relapsed/refractory patients.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- WHO performance status = 50% (Karnofsky) or = 3 (ECOG).
- 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.
- 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.
See the full eligibility criteria
- 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.
- WHO performance status = 50% (Karnofsky) or = 3 (ECOG).
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.