Stopping tyrosine kinase inhibitors a second time after first unsuccesful treatment discontinuation in chronic myeloid leukemia

Phase 1

• Conditions: CML-Patients in chronic phase having failed a prior attempt to stop imatinib or other TKIs therapy either within EURO-SKI or not and are pretreated at least one year with any TKI after 1st stop; MedDRA version: 19.1Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-004998-33-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-23
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•Age = 18 years
•Patients with Ph -chromosome and/or the BCR-ABL fusion gene (either b3a2 and/or b2a2) positive CML
•CML in CP having failed a prior attempt to stop imatinib or other TKIs therapy either within EURO-SKI or not
•Pretreatment at least one year with any TKI after 1st stop
•Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

•Previous hematological relapse after first stop of TKI.
•Failure to any TKI at any time during CML treatment TKI according to actual ELN criteria
•Previous planned or performed allo SCT
•Previous AP/BC at any time in the history of the disease
•High cardiac risk according to ESC Score
•Contraindication against nilotinib (see following)
•Impaired cardiac function including any of the following:
oUse of a ventricular paced pacemaker; congenital long QT syndrome or family history of; history or presence of significant ventricular or atrial tachyarrhythmias; clinically significant resting bradycardia (<50 bpm); QTcF >450 msec at baseline, myocardial infarction before baseline; other clinically significant heart disease (e.g., unstable angina, congestive heart failure, or uncontrolled hypertension).
•Treatment with inhibitors of CYP3A4 or medications that have been well documented to prolong the QT interval is contraindicated.
•History of acute pancreatitis within one year of study entry or medical history of chronic pancreatitis.
•Positive hepatitis B virus serology test or HBV infection
•Any other malignancy except if neither clinically significant nor requires active intervention.
•Severe or uncontrolled medical conditions (i.e., uncontrolled diabetes, acute or chronic liver disease, pancreatic, or severe renal disease unrelated to tumor, active or uncontrolled infection).
•Women who are pregnant, breast feeding, or of childbearing potential without a negative serum pregnancy test at baseline. Male or female patients of childbearing potential unwilling to use an effective barrier contraceptive method.

Study & Design

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