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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT00377104
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of 1 of the following:
* B-cell chronic lymphocytic leukemia (CLL)
* Small lymphocytic lymphoma (SLL)
* Must have received 1-3 prior therapies for CLL
* Completed therapy 2-12 months ago
* Prior therapy must have led to a partial response or greater
* No evidence of progressive disease
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,000/mm³
* WBC ≤ 5,000/mm³
* Platelet count ≥ 50,000/mm³
* Cytopenia allowed
* Creatinine \< 2.0 mg/dL
* Bilirubin ≤ 1.5 times normal (unless due to Gilbert's disease or hemolysis)
* AST ≤ 2 times normal (unless due to hemolysis)
* No secondary malignancy or other disease that would limit survival to \< 2 years
* No history of inflammatory bowel disease unless inactive for \> 2 years
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* See Disease Characteristics
* No other concurrent chemotherapy
* No concurrent radiotherapy
* No concurrent dexamethasone or other corticosteroid-based antiemetics
* No concurrent chronic corticosteroid therapy
* No other concurrent hormonal therapy except for the following:
* Steroids for new adrenal failure
* Hormones for nondisease-related conditions (e.g., insulin for diabetes)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00377104
Study Brief:
Protocol Section:
NCT00377104