None listed
Conditions
Interventions
Patients will receive a daily oral administration of STI571 at a dose of 400 mg for 12 months (Part 1). After completing 12 months of therapy, patients may be eligible to receive additional therapy (Part 2) if it is proven that, in the opinion of the investigator, the patient benefits from treatment with STI571 and in the absence of any concerns regarding the security.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Men and women> 18 years of age. • Patients with confirmed diagnosis of CML positive Ph chromosome in chronic phase • Patients must have refractivity or documented resistance to an interferon alpha defined as one of the following postulates: o Hematological resistance: failure to achieve a complete hematological response, lasting at least one month despite 6 or more months of a treatment regimen containing interferon alfa (at least 25 million international units (MIU) per week) . o Cytogenetic resistance: Cytogeny of the bone marrow with> 65% of Ph positive chromosome, after at least one year of therapy based on interferon alfa. o Cytogenetic refractoriness: An increase in the Ph positive chromosome cells of the bone marrow of at least 30 percentage points (for example, from 20% to 50%, or from 30% to 60%) confined by two samples with at least one month of difference, or an increase> 65% o Hematologic refractoriness - A rising white blood cell count (> 100% increase and up to a level> 20 x 10 9 / L confirmed by two samples at least two weeks apart) while receiving a regimen containing interferon alpha (at least 25 MIU) per week). • Patients who have shown intolerance to interferon alpha therapy defined as: Grade> 3 documented non-haematological toxicity, persistent for more than one month in a patient receiving a regimen containing interferon alfa. Patients who are intolerant to interferon alfa should be diagnosed more than three months. • Written informed consent given voluntarily
Exclusion criteria
Exclusion criteria: • Patients with the ability to procreate without a negative pregnancy test prior to the beginning of the ingestion of experimental medication. Physical barrier contraceptive measures should be used in both sexes throughout the study. • Serum creatinine and bilirubin concentrations greater than twice the upper limit of the normal range. • SGOT (AST) and SGPT (ALT) greater than twice the upper limit of the normal range. • Percent blasts or basophils in peripheral blood or bone marrow> 15%. • Percentage of blisters plus promyelocytes in peripheral blood or bone marrow> 30%. • Patients with platelet count 3. • Patients receiving busulfan within 6 weeks of Visit 1. • Patients receiving treatment with interferon-alpha within 14 days of Visit l. • Patients receiving treatment with cytosine arbinoside within 14 days of Visit 1. • Patients receiving hydroxyurea treatment within 7 days of Visit 1. • Patients who have received other experimental agents within 28 days of the Visit • Patients with cardiac problems Grade 3/4 defined according to the criteria of the New York Heart Association. • Patients with a history of non-compliance with medical regimens or who are considered potentially untrustworthy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Hematological and blood biochemistry tests Measure:Hematological Response Timepoints:In each of the 49 weeks that the treatment lasts. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Analysis of bone marrow The decrease in the percentage of cells with positive Ph chromosome in the bone marrow in this population of patients will be evaluated. Measure:Cytogenic response Timepoints:Weeks 13, 25, 37 and 49 ; Outcome name:Clinical evaluation of symptoms related to cancer Measure:Symptomatic improvement Timepoints:Weeks 13, 25, 37 and 49 ; Outcome name:Adverse events, laboratory data (SGOT, SGTP, bilirubin, alkaline phosphatase and LDH) will be recorded Measure:Frequency of adverse events and the number of laboratory values that are outside the predetermined ranges Timepoints:The registration will take place at the moment of the appearance of the event. | — |
Outcome results
None listed