EWALL-Ph-03

Phase 1

• Conditions: Philadelphia chromosome positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukaemia (ALL); MedDRA version: 21.0 Level: LLT Classification code 10000844 Term: Acute lymphoblastic leukaemia System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003350-25-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-18
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

•Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukaemia
•Male or female patients > 55 years (biological age)
•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 male subjects whose sexual partners are women of child-bearing potential (WOCBP), to use an effective form of contraception (pearl index < 1%) during the study and at least 6 months thereafter.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

•Patient previously treated with tyrosine kinase inhibitors
•Known impaired cardiac function (detailed in protocol)
•History or presence of clinically relevant CNS pathology (detailed in protocol)
•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
•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
•Patients unwilling or unable to comply with the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified