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The study aims to verify the greater efficacy of the treatment of Acute Lymphoblastic Leukemia Ph + through the combination of Ponatinib and Blinatumomab, a specific monoclonal antibody, in adult patients, compared to the administration of chemotherapy and Imatinib. ALL2820
EU CTIS ID: 2023-508968-30-00
What this study is testing
To explore the efficacy of a front-line chemo-free strategy based on the administration of Ponatinib plus steroids as induction treatment, followed by the infusion of Blinatumomab as consolidation in adult Ph+ ALL (=18 years, no upper age limit), and to compare it with a chemotherapy scheme combined with Imatinib (control arm), in terms of event-free survival (EFS), a composite endpoint, with events defined as: non achievement of MRD negativity (CMR or PNQ), deaths for any reason, toxicity and resistance (due or not to an ABL1 mutation development) in adult Ph+ ALL (=18 years, no upper age limit).
- Therapeutic confirmatory (Phase III)
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
- Signed written informed consent according to ICH/EU/GCP and national local laws.
- Negative pregnancy test in women of childbearing potential.
- Bone marrow specimen from primary diagnosis available.
- Newly diagnosed adult B-precursor Ph+ ALL patients.
- WHO performance status less or equal to 2.
- Age greater or equal to18 years, with no upper age limit.
You likely can't join if
- History of or current relevant CNS pathology (ongoing grade =2 epilepsy, seizure, paresis, aphasia, clinically relevant apoplexia, severe brain injuries, dementia, Parkinson’s disease, organic brain syndrome, psychosis).
- Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix.
- Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator.
- Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.
- Impaired cardiac function, including any one of the following: - LVEF <45% as determined by MUGA scan or echocardiogram. - Complete left bundle branch block. - Use of a cardiac pacemaker. - ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads. - Congenital long QT syndrome. - History of or presence of significant ventricular or atrial arrhythmia. - Clinically significant resting bradycardia (<50 beats per minute). - QTc >450 msec on screening ECG (using the QTcF formula). - Right bundle branch block plus left anterior hemiblock, bifascicular block. - Myocardial infarction within 3 months prior to starting Ponatinib. - Angina pectoris.
- Other clinically significant vascular and heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
See the full eligibility criteria
- Signed written informed consent according to ICH/EU/GCP and national local laws.
- Negative pregnancy test in women of childbearing potential.
- Bone marrow specimen from primary diagnosis available.
- Newly diagnosed adult B-precursor Ph+ ALL patients.
- WHO performance status less or equal to 2.
- Age greater or equal to18 years, with no upper age limit.
- Renal and hepatic function as defined below: - AST (GOT), ALT (GPT), and AP <2 x upper limit of normal (ULN). - Total bilirubin <1.5 x ULN. - Creatinine clearance equal or greater than 50 mL/min.
- Pancreatic function as defined below: - Serum amylase less or equal to 1.5 x ULN and serum lipase less or equal to1.5 x ULN.
- Normal cardiac function.
- No evidence of CNS leukemia at blinatumomab start.
- Negative HIV test, negative hepatitis B (HBsAg) and hepatitis C virus (anti-HCV) test.
- History of or current relevant CNS pathology (ongoing grade =2 epilepsy, seizure, paresis, aphasia, clinically relevant apoplexia, severe brain injuries, dementia, Parkinson’s disease, organic brain syndrome, psychosis).
- Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix.
- Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator.
- Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.
- Impaired cardiac function, including any one of the following: - LVEF <45% as determined by MUGA scan or echocardiogram. - Complete left bundle branch block. - Use of a cardiac pacemaker. - ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads. - Congenital long QT syndrome. - History of or presence of significant ventricular or atrial arrhythmia. - Clinically significant resting bradycardia (<50 beats per minute). - QTc >450 msec on screening ECG (using the QTcF formula). - Right bundle branch block plus left anterior hemiblock, bifascicular block. - Myocardial infarction within 3 months prior to starting Ponatinib. - Angina pectoris.
- Other clinically significant vascular and heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Ponatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL).
- Taking medications that are known to be associated with Torsades de Pointes and medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib.
- History of or current autoimmune disease.
- Systemic cancer chemotherapy within 2 weeks prior to study.
- Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation.
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.
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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.