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To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.
Enrollment
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Inclusion criteria
Male or female patients ≥ 18 years of age.
ECOG 0, 1, or 2.
Have been diagnosed with Ph+ CML-CP and receiving imatinib therapy.
Patients with suboptimal molecular response to imatinib treatment continued for at least 18 months (first line therapy)
Suboptimal molecular response defined as all of the following conditions:
The treatment with imatinib defined as:
Dose of 300 mg or higher daily must be maintained for a minimum of 3 months prior to study entry.
Patients who meet the following laboratory tests criteria:
Written informed consent prior to any study related screening procedures being performed.
Exclusion criteria
Prior accelerated phase or blast crisis CML.
Previously documented T315I mutations.
Presence of chromosomal abnormalities other than Ph+.
Previous treatment with any other tyrosine kinase inhibitor except imatinib.
Impaired cardiac function including any one of the following:
Treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St John's Wort), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. See Section 6.4.3 for complete list of these medications.
Primary purpose
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Interventional model
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45 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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