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:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
NCT ID:
NCT00382200
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed myelodysplastic syndromes (MDS)
* International Prognostic scoring system (IPSS) score ≥ 0.5, including the following:
* Untreated or treated intermediate-1 risk disease
* Intermediate-2 risk disease
* High-risk disease
* No treatment-related MDS
* Ineligible for transplantation
* No decitabine-refractory disease defined as disease progression after discontinuation of therapy
* If previously treated with decitabine, must have responded to therapy (hematologic improvement or better per International Working Group Response Criteria)
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Bilirubin ≤ 2.5 mg/dL
* AST and ALT ≤ 2 times upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other medical condition that, in the opinion of the treating physician, would preclude patient compliance or put patient at excessive risk of treatment-related toxicity
* No other malignancy that would likely require systemic chemotherapy within 4 months after starting study treatment
* No allergy to parabens, vitamin A, or retinoids
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Prior azacytidine allowed
* More than 4 weeks since prior cytotoxic chemotherapy or radiotherapy
* More than 4 weeks since prior experimental therapy
* Concurrent myeloid growth factors allowed only in the setting of febrile neutropenia according to established guidelines for use
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00382200
Study Brief:
Protocol Section:
NCT00382200