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:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT01227135
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of chronic myeloid leukemia (CML) in chronic phase (CP)
* Has been treated with imatinib mesylate for at least 1 year
* Receiving a stable dose for ≥ 6 months prior to randomization
* Achieved at least major cytogenetic response (MCyR) and continues to be BCR/ABL-positive by quantitative polymerase chain reaction (Q-PCR)
* Must have a fusion gene present that can be monitored by Q-PCR
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm³ (stable and within normal range for ≥ 2 months)
* Platelet count ≥ 100,000/mm³ (stable and within normal range for ≥ 2 months)
* Serum albumin \> 3 g/dL
* AST and/or ALT ≤ 2.5 times upper limit of normal (ULN)
* Serum bilirubin ≤ 1.5 times ULN
* Serum creatinine ≤ 1.5 times ULN OR 24-hour creatinine clearance ≥ 50 mL/min
* Serum potassium ≥ lower limit of normal with or without replacement therapy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-method contraception (including a barrier method \[i.e., condom\]) during and for 3 months after completion of study therapy
* No impaired cardiac function, including any of the following:
* QTc \> 450 msec on screening ECG
* Congenital long QT syndrome
* History or presence of sustained ventricular tachycardia
* History of ventricular fibrillation or Torsades de pointes
* NYHA class III-IV congestive heart failure
* Uncontrolled hypertension
* No severe gastrointestinal (GI) disorder, uncontrolled epilepsy, known glucose-6-phosphate dehydrogenase (G6PD) deficiency, known porphyria, moderate or severe psoriasis, known myasthenia gravis, or other concurrent severe and/or uncontrolled medical conditions
* No preexisting maculopathy of the eye
* No significant history of noncompliance to medical regimens or the inability to grant a reliable informed consent
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy, investigational drug, or major surgery and recovered
* More than 6 months since change in imatinib mesylate dose
* No other concurrent anticancer therapy or radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01227135
Study Brief:
Protocol Section:
NCT01227135