BridgeMD
The study's aim is to treat adult patients affected by Ph-like ALL, a Philadelphianegative ALL subtype, with a combination of the tyrosine kinase inhibitor ponatinib and chemotherapy. The main objective of the trial is to improve the percentace of patients that achieve a disease remission also at the molecular level.
EU CTIS ID: 2023-510240-20-00
What this study is testing
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.
- 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
- Age18-65 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 aspartate aminotransferase (AST) =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.
You likely can't join if
- WHO performance status >2.
- 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
- 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.
See the full eligibility criteria
Who can join
- Age18-65 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 aspartate aminotransferase (AST) =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.
What rules you out
- WHO performance status >2.
- 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
- 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
- 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.
- 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.
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. 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.