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

Not Applicable

Completed

• 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

• Study Start: 2000-01-01
• Last Update Posted: 2023-09-04

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