Status:
UNKNOWN
Comparing Imatinib Standard Dose With Imatinib High Dose Induction in Pretreated Chronic Myeloid Leukemia (CML) Patients in Chronic Phase
Lead Sponsor:
Central European Leukemia Study Group
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will investigate the efficacy and tolerability of a short (6 months) high dose therapy followed by a standard dose compared to a continuous treatment with a standard dose of imatinib (Glive...
Detailed Description
Patients with CML not achieving or losing a major cytogenetic response on whatever palliative treatment for CML, are at high risk to progress to accelerated phase and blast crisis. A new promising tre...
Eligibility Criteria
Inclusion
- Patients \> 18 years of age
- BCR-ABL positive CML patients in chronic phase, confirmed by karyotype (Ph+) or RT-PCR.
- Patients pretreated with any drug that is known to control the disease of CML in chronic phase except imatinib (Glivec®).
- Patients without a major cytogenetic response at study entry (\> 35% Ph+ metaphases in bone marrow cytogenetic analysis performed \< 3 months before study entry).
- Patients either intolerant to interferon-alpha (non-hematologic toxicity grade 3-4 for more than 2 weeks) or having received pretreatment for CML at least 12 months before study entry.
- World Health Organization (WHO) status 0-2
- Adequate end organ function, defined as the following:
- total bilirubin \< 1.5 x upper limit of normal (ULN)
- SGOT and SGPT \< 2.5 x ULN
- creatinine \< 1.5 x ULN
- absolute neutrophil count (ANC) \> 1.5 x 10 \^ 9/L
- platelets \> 100 x 10 \^ 9/L
- Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
- Written voluntary informed consent.
Exclusion
- Patients eligible for allogeneic bone marrow transplantation.
- Patients in accelerated phase or blast crisis.
- Known tuberculosis or other uncontrolled infection.
- Other primary tumor of a different histological origin than the study indication (unless the relapse-free interval is \> 5 years, and with the exception of cervical carcinoma in situ \[CIS\], basal cell epithelioma, or squamous cell carcinoma of the skin).
- Major surgery within the last 14 days.
- Known to be HIV positive.
- Unstable medical disorder (except for indication) that excludes the patient in the opinion of the investigator.
- Patient has received any other investigational agents within 28 days of first day of study drug dosing.
- Patients with a WHO performance status score \> 3
- Patients with Grade III/IV cardiac problems as defined by the New York Heart Association criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study).
- Female patients who are pregnant or breast-feeding.
- Refusal by female patients of childbearing age to use a safe contraceptive.
- Patients with known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
- Patients with any significant history of non-compliance to medical regimens or an inability to grant reliable informed consent.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2008
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00327262
Start Date
January 1 2004
End Date
December 1 2008
Last Update
June 20 2006
Active Locations (1)
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1
Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020