A STUDY TO DETERMINE THE EFFICACY AND SAFETY OF STI571 IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA IN ACCELERATED PHASE

Not Applicable

• Conditions: -C921 Chronic myeloid leukaemia [CML], BCR/ABL-positive; Chronic myeloid leukaemia [CML], BCR/ABL-positive; C921

• Registration Number: PER-073-00
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-01-01
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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%
o Percentage of blisters plus promyelocytes in peripheral blood or bone marrow> 30% (as long as <30% of blasts are present in the bone marrow)
o Peripheral basophils> 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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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)<br>Measure:Frequency of adverse events (safety)<br>Timepoints:Laboratory tests will be taken at each weekly visit and adverse effects will be recorded as they appear.<br>