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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT00290004
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years old
* CLL as defined by the NCI 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t\[11;14\] translocation or cyclin D1) or SLL as defined by WHO classification criteria and is refractory or relapsed as defined by one of the following:
* Refractory disease: progressive disease while on therapy
* Relapsed disease: progressive disease after at least one treatment course of therapy with disease response or stabilization
* ECOG performance status score of 0, 1, or 2
* Willing and able to provide written informed consent
Exclusion Criteria:
* Laboratory values of:
* Platelet count \< 30,000/µL
* AST or ALT \> 2 x ULN (upper limit of normal)
* Total bilirubin \> 2 x ULN
* Creatinine \> 2 mg/dL
* Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (\> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
* Major surgery or hospitalization for a serious illness within the last 3 months
* Greater than three prior regimens (where a regimen is defined as a treatment for CLL/SLL given initially or after disease progression)
* Prior malignancy requiring current or prior treatment within the past 5 years, except for cervical neoplasia in situ and non-melanomatous skin cancer
* Uncontrolled hypertension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00290004
Study Brief:
Protocol Section:
NCT00290004