None listed
Conditions
Interventions
Group 1 Type of group
Participants received 400 mg nilotinib twice daily (BID) orally.
Group name:Group 2 Type of group
Participants received 600 mg imatinib once daily (QD) orally.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Male or female, age> 18 years; • ECOG of O, 1 or 2; • Diagnosis of CMM Ph + in chronic phase (HR) at the beginning of treatment with imatinib 400 mg • Patients with suboptimal response to 400 mg of imatinib, (the cytogenic analysis to document the suboptimal response must have been performed within a maximum of 8 weeks before the first dose of the drug under study) • Patients receiving 400 mg / day of a standard dose of imatinib for at least 6 months and no more than 18 months; • That they have not been given imatinib in doses higher than 400 mg daily; • The previous use of IFN-a is allowed for a maximum of 1 month; • The following laboratory results should exist: Creatinine LIN [normal lower limit] or with supplements before the first dose of the study drug;
Exclusion criteria
Exclusion criteria: • CML in accelerated phase or blast crisis; • Previous treatment with imatinib in combination with any other drug; • More than 18 months (+8 weeks) of treatment with 400 mg of imatinib daily; • Patients receiving doses of 300 mg of imatinib daily; • T3151 mutation previously documented; • Reach a previous PCyR or RCC with imatinib and have lost said response before entering the study; • Previous treatment with any other tyrosine kinase inhibitor except imatinib; • Cardiac functioning disorders • Treatment with potent CYP3A4 inducers (such as dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbitol, St. John´s wort), and treatment cannot be interrupted or changed to a different medication before starting to deliver the study drug . See Section 6.1.3 for a complete list of these medications; • Treatment with potent CYP3A4 inhibitors (such as erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil), and treatment cannot be interrupted or changed to a different drug before starting to deliver the study drug. See Section 6.1.3 for a complete list of these medications; • It should be avoided to include patients taking a medication that has been documented to prolong the QT interval. In case it is not possible to avoid or change for another medication, the patient should be carefully monitored, having an ECG test every 3 months once the study is started, or if there is a change in the dose or clinical symptoms appear; • Impaired gastrointestinal (GI) function or GI disease that can significantly alter the absorption of the study drug (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, intolerance syndrome, surgery of the small intestine or gastric bypass surgery) . • History of acute pancreatitis within the year prior to admission to the study or clinical history of chronic pancreatitis. • Cytopathological infiltration in the confirmed CNS (in the absence of suspected CNS intervention, a lumbar puncture is not required). • Pregnant women, who are breastfeeding or of childbearing age without a negative serum pregnancy test in the selection phase. • Male or female patients of childbearing age who refuse to use effective contraceptive methods during the trial. Post-menopausal women must have presented amenorrhea for at least 12 months to be considered as unable to procreate. • Patients with a history of another primary malignant tumor that is currently of clinical importance or requires active intervention. • Patients with other clinically significant medical or surgical disorders, which, at the discretion of the researchers, may make participation impossible. • Use of research agents in the 28 days prior to participation in the study or intended use of a research agent during the study; • Patients who do not wish or cannot comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow. Measure:Percentage of Participants With Complete Cytogenetic Response (CCyR) Timepoints:6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:PFS was defined as the time from the date of randomization to the date of documented disease progression to accelerated phase or blast crisis (AP/BC), or death due to any cause. Measure:Progression-Free Survival (PFS) Timepoints:24 months ; Outcome name:EFS was defined as the time from the date of randomization to the date of the first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of Partial Cytogenetic Response (PCyR), loss of CCyR, death on treatment or progression to AP/BC. Measure:Event-Free Survival (EFS) Timepoints:24 months ; Outcome name:OS was defined as time from date of randomization to the date of the death. Measure:Overall Survival (OS) Timepoints:24 months ; Outcome name:MMR was defined as having a fusion gene of the Bcr and Abl genes of (BCR-ACL) less than or equal to 0.1% on the International Scale (IS). Measure:Percentage of Participants With Major Molecular Response (MMR) Timepoints:12 and 24 months ; Outcome name:CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow. Measure:Percentage of Participants With CCyr Timepoints:12 and 24 months ; Outcome name:Time to CCyR was defined as time from date of randomization to date of first documented CCyR. Measure:Time to CCyR Timepoints:24 months ; Outcome name:Duration of CCyR was defined as time from the date of ransomization to the date of first loss of CCyR or death, whichever came first. Measure:Duration of CCyR Timepoints:24 months | — |
Countries
Argentina, Brazil, China, Colombia, Germany, Guatemala, India, Mexico, Panama, Peru, Poland, Russian Federation, Venezuela
Contacts
Public ContactJuan Reyes
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed