chronic myeloid leukemia
Conditions
Interventions
CP-CML patients starting treatment with nilotinib are followed up for at least 12 months.
Sponsors
VU University Medical Center Amsterdam
Eligibility
Inclusion criteria
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
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. - Inability to grant consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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.; patients’ 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. | — |
Contacts
Public ContactChristel Boons
VU University Medical Center, Clinical Pharmacology and Pharmacy, De Boelelaan 1117
Outcome results
None listed