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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT00015951
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed poor-risk hematologic malignancy
* Relapsed or refractory acute myelogenous leukemia (AML)
* Primary induction failure
* Myelodysplasia(MDS)-related AML
* Secondary AML
* Relapsed or refractory MDS
* Primary induction failure
* Refractory anemia with excess blasts (RAEB)
* RAEB in transformation
* Chronic myelomonocytic leukemia
* Chronic myelogenous leukemia in blast crisis
* Failure of prior primary induction therapy or relapse after achieving complete remission allowed only if no more than 3 courses of prior induction/reinduction therapy were received
* No hyperleukocytosis (50,000 or more leukemic blasts/mm3)
* No active CNS leukemia
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
* No disseminated intravascular coagulation
Hepatic:
* AST/ALT no greater than 2 times normal
* Alkaline phosphatase no greater than 2 times normal
* Bilirubin no greater than 1.5 times normal
Renal:
* Creatinine no greater than 1.5 times normal
Cardiovascular:
* LVEF at least 45% by MUGA or echocardiogram
* No myocardial infarction within the past 3 months
* No history of severe coronary artery disease
* No cardiomyopathy
* No New York Heart Association class III or IV heart disease (congestive heart failure)
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active uncontrolled infection
* No history of cytarabine-related neurotoxicity
* No evidence of graft-versus-host disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 1 week since prior hematopoietic growth factors including epoetin alfa, filgrastim (G-CSF), and sargramostim (GM-CSF)
* At least 1 week since prior interleukin-3 or interleukin-11
* At least 4 weeks since prior autologous stem cell transplantation
* At least 90 days since prior allogeneic stem cell transplantation
* No other concurrent immunotherapy
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy and recovered
* No prior cytarabine administered as a 72-hour continuous infusion followed by mitoxantrone IV over 30 minutes
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* At least 2 weeks since prior immunosuppressive therapy
* No other concurrent investigational or commercially available antitumor therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00015951
Study Brief:
Protocol Section:
NCT00015951