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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT00077558
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* High-risk myelodysplastic syndromes (MDS), including refractory anemia with excess blasts and chronic myelomonocytic leukemia
* International Prognostic Scoring System (IPSS) score at least 1.5 based on the following:
* More than 10% marrow blasts
* Cytopenias in at least 2 lineages
* Adverse cytogenetics
* Acute myeloid leukemia (AML)
* All subtypes, including MDS/AML and treatment-related (secondary) AML
* Acute lymphoblastic leukemia
* Acute progranulocytic leukemia
* Ineligible for arsenic therapy
* Chronic myelogenous leukemia
* Accelerated phase or blastic crisis
* Chronic lymphocytic leukemia
* Prolymphocytic leukemia
* Received or ineligible for established curative regimens, including stem cell transplantation
* Acute and chronic leukemias must be relapsed and/or refractory with progressive disease since last therapy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* No history of hemolytic anemia grade 2 or greater
* No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
* G6PD screening required for high-risk groups (i.e., patients of African, Asian, or Mediterranean origin/ancestry)
Hepatic
* SGOT and SGPT no greater than 2.5 times normal
* Bilirubin no greater than 2 mg/dL
* No chronic hepatitis
Renal
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
Cardiovascular
* No active heart disease
* No myocardial infarction within the past 3 months
* No severe coronary artery disease
* No arrhythmias (other than atrial flutter or fibrillation) requiring medication
* No uncontrolled congestive heart failure
Pulmonary
* No dyspnea at rest or with minimal exertion
* No severe pulmonary disease requiring supplemental oxygen
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No neuropathy grade 2 or greater
* No active uncontrolled infection
* Infections under active treatment and controlled by antibiotics are allowed
* No other life-threatening illness
* No psychiatric illness that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* At least 1 week since prior hematopoietic growth factor (e.g., epoetin alfa, filgrastim \[G-CSF\], sargramostim \[GM-CSF\], interleukin-3, and interleukin-11)
* No concurrent immunotherapy
Chemotherapy
* Recovered from prior chemotherapy (no greater than grade 1 chronic toxic effects)
* At least 72 hours since prior hydroxyurea
* At least 3 weeks since prior myelosuppressive cytotoxic agents (6 weeks for mitomycin or nitrosoureas)
* No more than 12 prior courses of fludarabine
* No more than 3 prior cytotoxic chemotherapy regimens
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* At least 2 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* At least 1 week since prior non-myelosuppressive treatment
* No more than 4 prior induction regimens
* No other concurrent therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00077558
Study Brief:
Protocol Section:
NCT00077558