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EWALL-PH-03: An open label, 2-arm, Randomised phase II study to Compare the Safety and Efficacy of Ponatinib plus Chemotherapy with Imatinib plus Chemotherapy as front-line therapy for patients aged 55 years and over with Philadelphia chromosome positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL)
EU CTIS ID: 2023-505330-95-01
What this study is testing
To compare the molecular response to Ponatinib and Imatinib in combination with standard induction and consolidation 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
- Male or female patients > 55 years (biological age)
- Women of non-childbearing potential defined as sexually mature women who have undergone a hysterectomy or surgical sterilization or who have been naturally postmenopausal for at least 12 consecutive months (i.e., absence of menses in the preceding 12 consecutive months)
- Philadelphia chromosome- or BCR-ABL positive acute lymphoblastic leukemia
- Not previously treated except with corticosteroids, single dose vincristine or up to three doses of cyclophosphamide (maximum cumulative dose 1g/m2) or intrathecal therapy to control meningeal leukaemia
- No uncontrolled CNS involvement
- WHO performance status <2
You likely can't join if
- Patient previously treated with tyrosine kinase inhibitors
- Total bilirubin > 1.5 fold the institutional upper limit unless considered to be due to organ involvement by the leukemia or to M. Gilbert/M. Meulengracht
- Concurrent severe diseases which exclude the administration of therapy
- Chronic pancreatitis or acute pancreatitis within 6 months of study start
- Pregnant or lactating females
- Patients unwilling or unable to comply with the protocol
See the full eligibility criteria
Who can join
- Male or female patients > 55 years (biological age)
- Women of non-childbearing potential defined as sexually mature women who have undergone a hysterectomy or surgical sterilization or who have been naturally postmenopausal for at least 12 consecutive months (i.e., absence of menses in the preceding 12 consecutive months)
- Philadelphia chromosome- or BCR-ABL positive acute lymphoblastic leukemia
- Not previously treated except with corticosteroids, single dose vincristine or up to three doses of cyclophosphamide (maximum cumulative dose 1g/m2) or intrathecal therapy to control meningeal leukaemia
- No uncontrolled CNS involvement
- WHO performance status <2
- Normal serum levels > LLN (lower limit of normal) of potassium and magnesium, or corrected to within normal limits with supplements, prior to the first dose of study medication
- Signed written informed consent
- Molecular evaluation for BCR-ABL1 performed
- Willingness of sexually active male subjects whose sexual partners are women of childbearing potential (WOCBP), to use an effective form of contraception (pearl index < 1%) during the study and at least 6 months thereafter. Effective forms of contraception are complete sexual abstinence (refraining from heterosexual intercourse during the entire period of risk associated with the study treatments), combined oral contraceptive, hormone IUCD, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap/diaphragm with spermicide or surgical sterilisation (vasectomy) in male patients
What rules you out
- Patient previously treated with tyrosine kinase inhibitors
- Total bilirubin > 1.5 fold the institutional upper limit unless considered to be due to organ involvement by the leukemia or to M. Gilbert/M. Meulengracht
- Concurrent severe diseases which exclude the administration of therapy
- Chronic pancreatitis or acute pancreatitis within 6 months of study start
- Pregnant or lactating females
- Patients unwilling or unable to comply with the protocol
- Patients with history of hypersensitivity to any of the experimental treatments
- Known impaired cardiac function (if uncontrolled), including any of the following: • LVEF < 40% • Complete left bundle branch block • Right bundle branch block plus left anterior hemiblock, bifascicular block • History of or presence of clinically significant ventricular or atrial tachyarrhythmias • Clinically significant resting bradycardia (< 50 beats per minute) • Congenital long QT syndrome or QTcF >470 msec on screening ECG. If QTc > 470 msec and electrolytes are not within normal ranges before ponatinib dosing, electrolytes should be corrected and then the patient rescreened for QTcF criterion. • Myocardial infarction within 12 months prior to starting study treatment • Other clinical significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension)
- Symptomatic peripheral vascular disease
- Any history of ischemic stroke or transient ischemic attacks (TIAs)
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
- Active ALL in the CNS (confirmed by CSF analysis) or testes (by clinical assessment)
- Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) or active infection with Hepatitis B or C
- Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study
- Inadequate hepatic functions defined as ASAT or ALAT > 2,5 times the institutional upper limit of normal or > 5 times ULN if considered due to leukemia
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, 65+ years, 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.