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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT01263704
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, \>/= 65 years of age
* Previously untreated B-cell chronic lymphocytic leukemia (CLL)
* Binet stage C or active Binet stage A and B disease
Exclusion Criteria:
* Prior treatment for CLL
* CLL with transformation (Richter's syndrome)
* Suspected or known central nervous system (CNS) involvement of CLL
* Impaired renal or hepatic function
* Human Immunodeficiency Virus (HIV) positivity, active hepatitis B/C or Hepatitis B Virus (HBV) surface antigen positive, or any active or uncontrolled infections
* Patients with anti-HBV core antibodies (past infection with HBV) but who are negative for Hepatitis B Virus Surface Antigen (HBVsAg) (either anti-HBS Ab positive or negative) and are positive for HBV- Deoxyribonucleic acid (DNA) by Polymerase chain reaction (PCR) analysis
* Concomitant diseases requiring chronic steroid administration
* Active second malignancy within the 2 years prior to study (except for non-melanoma skin cancer and in situ cervix or breast or prostate carcinoma)
* Eastern Cooperative Oncology Group (ECOG) performance status \>/= 3
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01263704
Study Brief:
Protocol Section:
NCT01263704