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Response and Adherence to Nilotinib in Daily Practice


- candidate number14891
- NTR NumberNTR3992
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mei-2013
- Secondary IDsNL41762.029.13 METc VUmc
- Public TitleResponse and Adherence to Nilotinib in Daily Practice
- Scientific TitleResponse and Adherence to Nilotinib in Daily Practice
- ACRONYMRAND-study
- hypothesisThe present study aims to get more insight into the efficacy of treatment with nilotinib and the various aspects that govern optimal response, of which adherence is a primary endpoint. We hypothesize that patients who experience inadequate response levels to nilotinib are less adherent. In addition, their plasma levels of nilotinib may be lower.
- Healt Condition(s) or Problem(s) studiedChronic myeloid leukemia
- Inclusion criteria- Male or female patients > 18 years of age;
- ECOG 0, 1, or 2;
- Patients with CML-CP within 6 months of diagnosis;
- Diagnosis of chronic myelogenous leukemia in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations;
- Ability to provide written informed consent prior to any study related screening procedures being performed.
- Exclusion criteria- Patients who are considered Ph negative because they do not have a confirmed cytogenetic diagnosis of Philadelphia chromosome of (9,22) translocation;
- Previously documented T315I mutations;
- Treatment with tyrosine kinase inhibitor(s) prior to study entry is not allowed, except in the following situation: in emergent cases where the patient requires disease management while awaiting study start, commercial supplies of Glivec at any dose may be prescribed to the patient but for no longer than 2 weeks in duration;
- Any medical treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide ;
- All other criteria based on the treatment guidelines.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2013
- planned closingdate1-jan-2016
- Target number of participants70
- InterventionsNewly-diagnosed intermediate and high-risk CP-CML patients starting treatment with nilotinib are followed up for at least 12 months.
- Primary outcome1. CCyR within 12 months after the start of first study medication.
2. Adherence: the daily intake of nilotinib capsules as counted by means of a MEMS.
- Secondary outcome1. CyR at 3, 6 and 12 months after the start of the first study medication;
2. MMR within 18 months after the start of the first study medication;
3. CHR
4. CMR
5. trough plasma level of nilotinib
6. Potential drug-drug interactions
7. Patient-reported side effects
8. Adherence by means of telephonic pill count
9. Adherence behaviour by means of the Medication Adherence Rating Scale (MARS)
10. Quality of life by means of the SF-12 Health Survey
11. Attitude towards disease by means of the Brief Illness Perception Questionnaire (Brief IPQ)
12. Attitude towards medication by means of the Beliefs about Medicines questionnaire (BMQ)
13. Patients appreciation of information received about the medication by means of the Satisfaction with Information about Medicines Scale (SIMS)
14. patient-reported discontinuation
15. patient demographics
- TimepointsBaseline and after 3, 6 and 12 months of treatment.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Christel Boons
- CONTACT for SCIENTIFIC QUERIESDr. J.G. Hugtenburg
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Novartis
- PublicationsBoons CCLM, Swart EL, Timmers L, Janssen JJWM, van de Ven PM, Hugtenburg JG. Study protocol of the RAND-study: a multicenter, prospective cohort study investigating response and adherence to nilotinib treatment in chronic myeloid leukemia. BMC Cancer 2014, 14:247.
- Brief summary23-mei-2014:
Background
The antitumor drug nilotinib has a large inter- and intra individual variability in pharmacokinetics. Adherence to treatment may substantially influence plasma levels and has been recognized as the most important determinant of treatment failure in chronic myeloid leukemia (CML). A better understanding of the various factors contributing to the efficacy of treatment is essential for the development of interventions to optimize the treatment of chronic phase CML (CP-CML) with a protein kinase inhibitor like nilotinib.

Methods/Design In this multicenter prospective observational cohort study 70 adult patients with CP-CML starting treatment with nilotinib will be followed up for at least 12 months. Response to treatment is evaluated after 3, 6 and 12 months. Adherence is primarily assessed by counting the daily intake of nilotinib capsules by means of a medication event monitoring system (MEMS). Before the start of nilotinib treatment and after 3, 6 and 12 months, patients are asked to fill in a comprehensive questionnaire including topics on quality of life, side effects, attitude towards disease and medication, the patientsí appreciation of information received about the medication, and discontinuation, and trough plasma levels of nilotinib are measured.
- Main changes (audit trail)23-mei-2014: Various changes:

Inclusion criteria:
- Male or female patients ≥ 18 years of age;
- ECOG 0, 1, or 2;
- Diagnosis of chronic myelogenous leukemia in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations;
- Starting treatment with nilotinib;

Exclusion criteria: - Inability to grant consent.

Interventions: CP-CML patients starting treatment with nilotinib are followed up for at least 12 months

Primary outcome
1. MMR within 12 months after the start of first study medication.
2. Adherence: the total intake of nilotinib capsules as counted by means of a MEMS taken as percentage of the number of pills prescribed over the 12 months follow-up period.

Secondary outcome: Rates of complete hematological response (CHR; the normalization of the blood cell count), CCyR (complete absence of Ph+ cells in blood and bone marrow), and complete molecular response (CMR)(using RQ-PCR Ph+ DNA cannot be detected); trough plasma level of nilotinib; potential drug-drug interactions; patient-reported side effects; adherence by means of telephonic pill count; adherence behaviour by means of the Medication Adherence Rating Scale (MARS); quality of life by means of the SF-12 Health Survey; attitude towards disease and medication by means of the Brief Illness Perception Questionnaire (IPQ) and the Beliefs about Medicines questionnaire (BMQ), resp.; patientsí appreciation of information received about the medication by means of the Satisfaction with Information about Medicines Scale (SIMS); percentage of dose adjustment; patient-reported discontinuation; and patient demographics.

- RECORD14-mei-2013 - 23-aug-2014


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