- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00514969
Protein-Tyrosine Kinase Inhibitor (STI571) for Treatment of Patients With Ph+ Chronic Myeloid Leukemia in Accelerated and Blastic Phase (CML003)
August 9, 2007 updated by: University of Bologna
Protein-Tyrosine Kinase Inhibitor (STI571) for Treatment of Patients With Ph+ Chronic Myeloid Leukemia in Accelerated and Blastic Phase. A Phase II Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bologna, Italy
- Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female patients * 18 years of age
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.
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).
- Voluntary written informed consent.
Exclusion Criteria:
- 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.
- Patients with an ECOG Performance Status Score ** 3 (see Section 7.2.1)
- Creatinine levels more than 2 x's the ULN at the laboratory where the analysis was performed.
- 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
- 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
- Patients receiving treatment with interferon-alpha within 48 hours of Day 1.
- Patients receiving treatment with hydroxyurea within 24 hours of Day 1
- Patients receiving treatment with homoharringtonine within 14 days of Day 1
- Patients receiving treatment with low-dose cytosine arabinoside (< 30 mg/m2 every 12 to 24 hours administered daily) within seven days of Day 1
- Patients receiving treatment with moderate dose cytosine arabinoside (100-200 mg/m2 for 5 to 6 days) within 14 days of Day 1.
- 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.
- Patients receiving anthracyclines, mitoxantrone, etoposide, methotrexate or cyclophosphamide within 21 days of Day1.
- Patients receiving busulfan within six weeks of Day 1.
- Patients receiving anti-leukemic agents not included in Exclusion Criteria 6-13 should not begin treatment with STI571 until sufficient time has elapsed for potential recovery to have occurred in the nadir in blood counts. In practice, a full recovery of blood counts may not be possible due to progression of the underlying disease.
- Patients receiving any hematopoietic stem cell transplantation and who have not achieved full hematopoietic recovery following the transplant
- Patients receiving any other investigational agents within 28 days of Day 1.
- Patients with Grade ¾ cardiac disease.
- Patients with any serious concomitant medical condition
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
- Patients with a prior diagnosis of accelerated or blastic phase who are in remission and do not fit inclusion criteria, are not eligible.
- Patients who are likely to be submitted to any procedure of stem cell transplantation before the end of the treatment (6 months), are not eligible.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine the rate of hematological response lasting * 4 weeks in adult patients with Ph chromosome positive CML in accelerated and blastic phase
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Secondary Outcome Measures
Outcome Measure |
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duration of hematological response and overall survival, cytogenetic response and safety
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2000
Study Registration Dates
First Submitted
August 9, 2007
First Submitted That Met QC Criteria
August 9, 2007
First Posted (ESTIMATE)
August 10, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
August 10, 2007
Last Update Submitted That Met QC Criteria
August 9, 2007
Last Verified
July 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Neoplastic Processes
- Cell Transformation, Neoplastic
- Carcinogenesis
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Blast Crisis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
Other Study ID Numbers
- CML003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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