The primary study objective is to assess whether CML patients who respond to treatment with nilotinib (MMR within 12 months of treatment) differ from the non-responders in terms of adherence. Secondary objective is to evaluate whether responders and…
ID
Source
Brief title
Condition
- Leukaemias
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy endpoint is the MMR within 12 months after the start of
first study medication. A MMR is defined as <=0.1% BCR-ABL/ABL in the
international scale.
The primary means of assessing adherence is the total intake of nilotinib
capsules as counted by means of a medication event monitoring system, taken as
percentage of the number of capsules prescribed over the 12 months follow-up
period.
Secondary outcome
Secondary parameters include:
- complete hematological response (CHR; the normalization of the blood cell
count, particularly of white blood cells)
- complete cytogenetic response (CCyR, complete absence of Ph+ cells in blood
and bone marrow)
- complete molecular response (CMR)(using RQ-PCR Ph+ DNA cannot be detected)
- trough plasma level of nilotinib
- potential drug-drug interactions based on patient-reported data from the
questionnaire, data from the patient's medical file and pharmacy dispension
records of the past 6 months
- patient-reported side effects data obtained by means of questionnaires
- adherence by means of the conventional PPP method (Patient*s files-Pharmacy
records-Pill count method).
- adherence behaviour data obtained by means of the Medication Adherence Rating
Scale (MARS) questionnaire.
- quality of life data obtained by means of the SF-12 Health Survey
- attitude towards disease data obtained by means of the Brief Illness
Perception Questionnaire (Brief IPQ)
- beliefs about medicines data obtained by means of the Beliefs about Medicines
Questionnaire (BMQ)
- patients* appreciation of information given about the medication obtained by
means of the Satisfaction with Information about Medicines Scale (SIMS)
questionnaire
- percentage of dose adjustment
- patient-reported discontinuation by means of questionnaire.
Background summary
Nilotinib is indicated for the treatment of chronic myeloid leukemia (CML). The
antitumor drug nilotinib has a large inter- and intra individual variability of
pharmacokinetics. Adherence to treatment may substantially influence plasma
levels. A better understanding of the various factors contributing to the
adherence to nilotinib treatment is essential for the development of
interventions to optimize the treatment of CML with a protein kinase inhibitor
like nilotinib.
Study objective
The primary study objective is to assess whether CML patients who respond to
treatment with nilotinib (MMR within 12 months of treatment) differ from the
non-responders in terms of adherence. Secondary objective is to evaluate
whether responders and non-responders to nilotinib differ with respect to their
plasma levels of nilotinib. Furthermore, the study aims to identify possible
predictors for adherence to nilotinib treatment among a variety of hypothesized
predictors.
Study design
Multicenter prospective observational cohort study in which 70 patients with
CML on treatment with nilotinib will be followed up for at least 12 months.
Study burden and risks
Response to treatment will be evaluated at 3, 6 and 12 months of treatment,
and, for patients already on treatment at recruitment, also at study entry and
at the end of the 12 months follow-up period. Adherence is primarily assessed
by counting the total intake of nilotinib capsules by means of a medication
event monitoring system, taken as percentage of the number of capsules
prescribed. At baseline and after 3, 6 and 12 months, patients will be asked to
fill in a comprehensive questionnaire. After 3, 6 and 12 months and, for
patients already on treatment at recruitment, also at baseline, patients will
be asked to provide a blood spot sample.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Male or female patients >= 18 years of age
- ECOG 0, 1, or 2.
- Diagnosis of chronic myelogenous leukemia with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations.
- Treatment with nilotinib.
Exclusion criteria
- Inability to grant consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL41762.029.13 |
| OMON | NL-OMON23279 |