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 treatment, patients may be eligible for additional treatment (Part 2)
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 (or patients who are Ph chromosome negative but Bcr-Abl positive) in accelerated phase defined by the presence of one or more of the following criteria: o Percentage of blasts in blood or bone marrow> 15% but 30% (as long as 20% o Thrombocytopenia <100 x 10 ^ / L not related to therapy • Patients who meet the criteria mentioned above for the accelerated phase of the • CML must never have been in blast crisis before the start of study treatment. Patients with accelerated phase CML who are Ph chromosome negative but who are Bcr / Abl-positive are also eligible. • 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. • Patients with an ECOG performance status> 3 • Serum creatinine levels greater than 2 x the upper normal limit (LTLN) range in the laboratory where the test was performed. • Total serum bilirubin> 1.5 x LILN in the laboratory where the analyzes were performed; in patients with clinical suspicion of hepatic leukemic compromise, total bilirubin 3x the range of the upper normal limit (ULN). • AST (SGOT) and ALT (SGPT) greater than 3 x the upper normal limit (ULN) range in the laboratory where the analyzes were performed; in patients with clinical suspicion of hepatic leukemic compromise, AST and ALT greater than 5x the range of the upper normal limit (ULN). • Patients receiving treatment with interferon-alfa within 48 hours of Day 1. • Patients receiving hydroxyurea treatment within 24 hours of Day 1. • Patients receiving treatment with homobarringtonine within 14 days of Day 1. • Patients receiving treatment with low doses of cytosine arabinoside (<30 mg / m every 12 to 24 hours administered daily) within seven days of Day 1. • Patients receiving treatment with moderate doses of cytosine arabinoside (100-200 mg / m3 for 5 to 7 days) within 14 days of Day 1. • Patients receiving treatment with high doses of cytosine arabinoside (1-3 g / m each) • 12 to 24 hours for six to 12 doses) within 28 days of Day 1. • Patients receiving anthracyclines, mitoxantrone, etoposide, methotrexate or cyclophosphamide within 21 days of Day 1. • Patients receiving busulfan within six weeks of Day 1. • Patients receiving antileukemia agents not covered by exclusion criteria 6-12 should not start treatment with STI571 until sufficient time has elapsed for recovery to occur at the nadir of the counts. In practice, a complete recovery may not be possible due to the progression of the underlying disease. • Patients who receive any stem cell transplant within six weeks of day 1 or who have not achieved full hematopoietic recovery after transplantation. • Patients receiving any other experimental agent within 28 days of Day 1. • Patients with grade 3/4 heart disease. • Patients with any serious concomitant medical condition. • Patients with a history of non-compliance with medical regimens or who are considered potentially unreliable.
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:Hematology tests, liver biochemical blood function Measure:Hematological Response Timepoints:On each weekly visit ; 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:It is defined as the interval from the first day of treatment to 600 mg / d until the date of diagnosis of disease progression or discontinuation of treatment for any reason related to both the treatment and the underlying disease while receiving 600 mg / d. Measure:Time to treatment failure Timepoints:From the first day of treatment | — |
Outcome results
None listed