Chronic Myeloid Leukemia
Conditions
Keywords
accelerated and blastic phase, STI571
Brief summary
This is a phase II, multi-center, open-label, non-randomized trial. During Part 1 of the trial, patients will receive once daily oral administration of STI571 at a dose of 600 mg for 24 weeks. After completing 24 weeks of therapy, patients may be eligible to receive additional therapy during Part 2 of the trial provided that, in the opinion of the investigator, the patient has benefited from treatment with STI571 and in the absence of safety concerns. During Part 2 (which is of indefinite duration), patients will continue to receive STI571 on a daily basis until either death, the development of intolerable toxicity or the investigator feels it is no longer in the patient's best interest to continue therapy, whichever comes first.
Interventions
Sponsors
University of Bologna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients \* 18 years of age 2. Accelerated phase of CML defined as the presence of one or more of the following: * percentage of blasts in blood or bone marrow \* 15% but \< 30% * percentage of blasts plus promyelocytes in the peripheral blood or bone marrow \* 30% (providing that \< 30% blasts are present in the bone marrow) * peripheral basophils \* 20% * thrombocytopenia \< 100 x 109/L unrelated to therapy These criteria must be met within 4 weeks of administration of first dose of trial treatment. 3. Blastic phase of CML defined as the presence of one or more of the following: * percentage of blasts in blood or bone marrow \* 30% * percentage of blasts and promyelocytes in blood or bone marrow \* 50% * documented extramedullary blast involvement (skin, lymph node, bone, lung). 4. Voluntary written informed consent.
Exclusion criteria
1. Patients of childbearing potential wihout a negative pregnancy test prior to the initiation of study drug. Barrier contraceptive precautions are to be used throughout the trial in both sexes. 2. Patients with an ECOG Performance Status Score \*\* 3 (see Section 7.2.1) 3. Creatinine levels more than 2 x's the ULN at the laboratory where the analysis was performed. 4. Total serum bilirubin more than 1.5 x's the upper limit of the normal range (ULN) at the laboratory where the analyses were performed; in patients with clinically suspected leukemic involvement of the liver, total bilirubin more than 3 x's the ULN 5. AST (SGOT) or ALT (SGPT) more than 3 x's the upper limit of the normal range (ULN) at the laboratory where the analyses were performed; in patients with clinically suspected leukemic involvement of the liver, AST and ALT more than 5 x's the ULN 6. Patients receiving treatment with interferon-alpha within 48 hours of Day 1. 7. Patients receiving treatment with hydroxyurea within 24 hours of Day 1 8. Patients receiving treatment with homoharringtonine within 14 days of Day 1 9. Patients receiving treatment with low-dose cytosine arabinoside (\< 30 mg/m2 every 12 to 24 hours administered daily) within seven days of Day 1 10. Patients receiving treatment with moderate dose cytosine arabinoside (100-200 mg/m2 for 5 to 6 days) within 14 days of Day 1. 11. Patients receiving treatment with high-dose cytosine arabinoside (1-3 g(m2 every 12 to 24 hours for six to 12 doses) within 28 days of Day 1. 12. Patients receiving anthracyclines, mitoxantrone, etoposide, methotrexate or cyclophosphamide within 21 days of Day1. 13. Patients receiving busulfan within six weeks of Day 1. 14. Patients receiving anti-leukemic agents not included in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the rate of hematological response lasting * 4 weeks in adult patients with Ph chromosome positive CML in accelerated and blastic phase | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of hematological response and overall survival, cytogenetic response and safety | — |
Countries
Italy
Outcome results
None listed