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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT00020969
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of myelodysplastic syndromes (MDS)
* Refractory anemia (RA)
* RA with ringed sideroblasts
* RA with excess blasts (RAEB)
* RAEB in transformation
* Chronic myelomonocytic leukemia
* Low-risk MDS patients:
* If serum erythropoietin less than 200 IU/mL, must have failed prior recombinant epoetin alfa (EPO) trial
* No prior acute myeloid leukemia
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100%
Life expectancy:
* More than 3 months
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2.5 times upper limit of normal (ULN)
* SGPT and SGOT no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* Absolute QT interval less than 460 msec in the presence of magnesium greater than 1.8 mg/dL and potassium greater than 4.0 mEq/L
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* At least 30 days since prior biologic therapy (except recombinant EPO in low-risk MDS patients)
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 30 days since prior radiotherapy
Surgery:
* Not specified
Other:
* At least 30 days since prior cytotoxic agents
* At least 30 days since prior investigational agents
* No prior arsenic trioxide
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00020969
Study Brief:
Protocol Section:
NCT00020969