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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT00114257
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following hematologic malignancies:
* Acute myeloid leukemia
* Previously untreated patients \> 60 years of age who are not eligible for front-line therapy are eligible for this study
* Acute lymphoblastic leukemia
* Chronic myelogenous leukemia (CML)
* Documented hematologic resistance to imatinib mesylate OR no cytogenetic response after 12 months of prior treatment with imatinib mesylate
* Philadelphia chromosome-negative CML allowed provided disease is resistant to standard therapy (e.g., hydroxyurea) OR disease progressed (blasts \> 5% and platelet count \< 100,000/mm\^3) during standard therapy
* Myelodysplastic syndromes
* International Prognostic Scoring System risk category ≥ intermediate-1
* Patients who are not eligible for front-line therapy are eligible for this study
* Myeloproliferative disease
* Chronic lymphocytic leukemia
* Failed or progressed during ≥ 1 prior fludarabine-based therapy AND alemtuzmab
* Acute promyelocytic leukemia
* Progressed after prior treatment with standard chemotherapy, tretinoin, and arsenic trioxide
* Chronic myelomonocytic leukemia
* Resistant to standard therapy (e.g., hydroxyurea) OR disease progressed (blasts \> 5% and platelet count \< 100,000/mm\^3) during standard therapy
* Relapsed or refractory disease
* No known brain or meningeal disease
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-1
Life expectancy
* More than 8 weeks
Hepatic
* Bilirubin \< 2 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal
Renal
* Creatinine \< 2 mg/dL
Cardiovascular
* QTc \< 500 msec
* LVEF \> 40% by MUGA
* No New York Heart Association class III or IV congestive heart failure
* No myocardial infarction within the past year
* No uncontrolled dysrhythmias
* No uncontrolled angina
* No left ventricular hypertrophy by EKG
* No history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
* No other significant cardiac disease
Immunologic
* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs
* No ongoing or active infection
* No HIV positivity
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Chemotherapy
* Recovered from prior chemotherapy
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) unless there is evidence of rapidly progressive disease
Radiotherapy
* At least 4 weeks since prior radiotherapy and recovered
Other
* No concurrent agents that cause QTc prolongation
* No other concurrent investigational or commercial agents or therapies for the malignancy
* No concurrent hydrochlorothiazide
* Concurrent potassium-conserving combinations (e.g., Maxide® or Dyazide®) or other antihypertensive agents allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00114257
Study Brief:
Protocol Section:
NCT00114257