Status:
NOT_YET_RECRUITING
Study in Adult Ph-positive ALL
Lead Sponsor:
Cardiff University
Conditions:
Acute Lymphoblastic Leukemia, Adult
Eligibility:
All Genders
55+ years
Phase:
PHASE2
Brief Summary
An Open Label, 3-arm, Randomised Phase II Study to Compare the Safety and Efficacy of Ponatinib in Combination With Either Chemotherapy or Blinatumomab With Imatinib Plus Chemotherapy as Front-line Th...
Detailed Description
Acute lymphoblastic leukemia (ALL) develops when a certain type of immature bone marrow cell called a lymphoblast becomes malignant, resulting in uncontrolled growth and suppression of normal blood ce...
Eligibility Criteria
Inclusion
- Male or female patients \> 55 years (biological age)
- Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukaemia
- 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 inform 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.
- 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., who has had menses any time in the preceding 12 consecutive months).
Exclusion
- Patient previously treated with tyrosine kinase inhibitors
- Known impaired cardiac function, 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
- History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis (with exception of CNS leukemia that is well controlled with intrathecal therapy)
- Active ALL in the CNS (confirmed by CSF analysis) or testes (by clinical assessment).
- Autoimmune disease with potential CNS involvement
- 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
- 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 as evidenced by clinical symptomatology and/or imaging within 6 months of study entry
- Pregnant or lactating females
- Patients unwilling or unable to comply with the protocol
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04688983
Start Date
January 1 2021
End Date
January 1 2026
Last Update
December 30 2020
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