None listed
Conditions
Interventions
Patients will receive a daily oral administration of STI571 at a dose of 600 mg for 12 months (Part 1). After completing 12 months of therapy, patients may be eligible to receive additional therapy (Part 2)
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female patients> 18 years of age. • Patients with confirmed diagnosis of CML positive Ph chromosome (or patients Ph chromosome negative but Bcr / Abl- positive) in myeloid blast crisis. Defined by the presence of one or more of the following postulates: or> 30% blasts in peripheral blood and / or in the bone marrow or by flow cytometry criteria o With extramedullary disease other than splenic, lymph node or liver involvement • SGOT and SGPT not greater than 3x the normal upper limit of the normal range (ULN) in the laboratory where the analyzes are performed. In patients in whom there is clinical suspicion of leukemic liver involvement, SGOT and SGPT should not be greater than 5 x ULN. • Total serum bilirubin levels not greater than 3x ULN in the laboratory where the analyzes are performed • Concentration of serum creatinine not greater than 2x ULN in the laboratory where the analyzes are performed • Patients of childbearing age should have a negative pregnancy serum test prior to the start of experimental medication. • Written informed consent given voluntarily
Exclusion criteria
Exclusion criteria: • Patients with ECOG performance status> 3 • Patients previously treated for the blast crisis should not have received any of the following: o Busulfan within 6 weeks of day 1 o Interferon - alpha within 48- hours of Day 1 o Hydroxyurea within 24 hours of Day 1 o Homoharringtonine within 14 days of Day 1 o Low doses of cytosine arabinoside (<30 mg / m ^ every 12 to 24 hours administered daily) within 7 days of Day 1 o Moderate doses of cytosine arabinoside (100-200 mg / m ^ for 5 to 7 days) within 14 days of Day 1 o High doses of cytosine arabinoside (1-3 g / m every 12 to 24 hours for 6 to 12 doses) within 28 days of Day 1 o Anthracycline, mitoxantrone or etoposide within 21 days of Day 1 o Any transplantation of precursor hematopoietic cells within 6 weeks of Day 1 • Patients who received another experimental medication within 28 days of Day 1. • Patients with grade 3/4 heart disease. • Patients with a history of non-compliance with medical regimens or considered potentially untrustworthy • Patients with any other serious concomitant medical condition • Patients of childbearing age without a negative serum pregnancy test before the start of the study. The physical barrier contraceptives should be used throughout the study by both sexes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse events will be summarized by means of the presentation of the number and the percentage of patients that experience an adverse event, by body system and severity. Laboratory data (SGOT, SGPT, bilirubin, alkaline phosphatase and LDH) Measure:Frequency of adverse events (safety) Timepoints:Laboratory tests will be taken at each weekly visit and adverse effects will be recorded as they appear. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Analysis of hematology, liver function and bone marrow Measure:Hematological response Timepoints:The haematological response should be confirmed after> 4 weeks. ; Outcome name:Cytogenic studies of bone marrow Measure:Cytogenetic response Timepoints:They will be made at the beginning and in Weeks 13, 25, 37 and 49, thereafter every six months, and also the last day of treatment ; Outcome name:Significant cancer-related symptoms (eg, fever, night sweats, bone pain, arthralgia, and abdominal discomfort) present prior to the start of the administration of the experimental medication should be included in the CRF of Cancer-related Symptoms . Measure:Cancer related symptoms Timepoints:They will be evaluated every three months during the first year of the study, and every six months thereafter and on the last day of treatment. ; Outcome name:Analysis of hematology, liver function and bone marrow Measure:Duration of the hematological response Timepoints:The haematological response should be confirmed after> 4 weeks. ; Outcome name:Defined as the interval from the first day of treatment (600 mg / day) at the date of diagnosis of disease progression, death or discontinuation of treatment for any reason, whether due to ongoing treatment or disease, or the date of the last follow-up if appropriate. Measure:Time to progression Timepoints:From the first day of treatment | — |
Outcome results
None listed