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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT01671904
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of relapsing/refractory or previously untreated CLL
* Eastern Cooperative Oncology Group (ECOG) performance score of less than equal to (\</=) 1
* Adequate bone marrow function
* Adequate coagulation, renal and hepatic function
* Hematological values within the limits independent of growth factor support or transfusion unless cytopenia is caused by the underlying disease, i.e., no evidence of additional bone marrow dysfunction (e.g., myelodysplastic syndrome, hypoplastic bone marrow)
Exclusion Criteria:
* Participants received an allogeneic stem cell transplant
* Known human immunodeficiency virus (HIV) positivity
* Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
* Positive test results for chronic hepatitis B infection and hepatitis C virus (HCV)
* Received any anti-cancer therapy including chemotherapy or radiotherapy, steroid therapy for anti-neoplastic intent, and investigational therapy, including targeted small molecule agents within 28 days prior to the first dose of study drug or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy
* Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01671904
Study Brief:
Protocol Section:
NCT01671904