Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT00081133
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of one of the following:
* Chronic myelogenous leukemia (CML) in one of the following phases:
* Blastic phase\*
* Accelerated phase\*
* No appropriate donors for stem cell transplantation NOTE: \*Must have received high-dose (600-800 mg/day) imatinib mesylate of no more than 3 months duration
* Acute lymphoblastic leukemia
* Philadelphia chromosome positive by cytogenetic confirmation
* Patients with only bcr-abl-positive disease by polymerase chain reaction are not eligible
* \> 10% blasts in the bone marrow
* No isolated extramedullary disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST ≤ 2 times ULN
* INR and PTT ≤ 1.5 times ULN (except for patients on anticoagulation therapy)
Renal
* Creatinine ≤ 2 times ULN
Cardiovascular
* Baseline QTc intervals \< 480 ms
* No chronic arrhythmias
* No active coronary artery disease
Other
* No chronic electrolyte abnormalities
* No prior non-compliance to medical regimens
* No patients who are considered potentially unreliable
* No active serious infection
* No other active malignancies except superficial epithelial cancers
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for at least 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior peripheral blood stem cell or bone marrow transplantation
Chemotherapy
* Prior hydroxyurea allowed
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* More than 4 weeks since prior major surgery and recovered
Other
* Prior anagrelide allowed
* No concurrent warfarin for therapeutic anticoagulation
* Concurrent low molecular weight heparin is allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00081133
Study Brief:
Protocol Section:
NCT00081133