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 @ 6:57 PM
Ignite Modification Date:
2025-12-24 @ 6:57 PM
NCT ID:
NCT00860457
Eligibility Criteria:
Inclusion Criteria:
* Understand and voluntarily sign informed consent form
* No prior therapy for CLL
* Able to adhere to study visit schedule and other protocol requirements
* CLL with any Rai Stage requiring therapy
* ECOG performance status \</= 2
* Absolute neutrophil count \>/= 1.0
* Platelet count \>/= 75
* Serum creatinine \</= 1.5
* Total bilirubin \</= 1.5
* AST and ALT \</= 2 x ULN
* Females of childbearing potential must have negative pregnancy test
* Disease free of prior malignancies for \>/= 5 years
* Able to take aspirin daily as prophylactic anticoagulation
Exclusion Criteria:
* Any serious medical condition, lab abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
* Pregnant or lactating females
* Any condition, including the presence of lab abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
* Use of any other experimental drug or therapy within 28 days of baseline
* Concurrent use of other anti-cancer agents or treatments
* Known positive for HIV or infectious active hepatitis, type A, B
* Known hypersensitivity to nucleoside analogue or rituximab
* Previous treatment for CLL prior to enrolling in study
* Known hypersensitivity to thalidomide
* The development of erythema nodosum if characterized by desquamating rash while taking thalidomide or similar drugs
* Any prior use of lenalidomide
* Active hemolysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00860457
Study Brief:
Protocol Section:
NCT00860457