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 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT01351935
Eligibility Criteria:
Inclusion Criteria:
* Women and men ≥18 years of age
* Body weight ≥50 kg.
* Confirmed diagnosis of B cellNon-Hodgkin Lymphoma(according to World Health Organization \[WHO\] classification)including Chronic Lymphocytic Leukemia/Small cell Lymphocytic Leukemia (International Workshop),or Waldenstrom's Macroglobulinemia(Second International Workshop)
* Have failed ≥1 previous treatment for B-NHL/CLL/WM, and have relapsed or refractory disease following last prior treatment.
* Eastern Cooperative Oncology Group performance status of ≤ 2 and a life expectancy of at least 3 months.
* Ability to swallow oral capsules without difficulty
* Has recovered from adverse toxic effects of prior therapies
* Meet the following clinical laboratory requirements:
* Creatinine ≤ 1.5 × upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 x ULN
* AST and ALT ≤ 3 × ULN
* Platelet count ≥ 50,000/µL (non-hodgkin \& Waldenstrom's)
* Platelet count ≥ 30,000/µL (chronic lymphocytic leukemia)
* Absolute Neutrophil count ≥ 1000/µL
Exclusion Criteria:
* Prior allogeneic bone marrow transplant
* Autologous stem cell transplant within 3 months of screening
* Active central nervous system involvement
* Subjects with autoimmune hemolytic anemia or immune thrombocytopenia
* Prior treatment with a Btk inhibitor
* Active uncontrolled infection
* History of malabsorption
* Uncontrolled illness, i.e cardiac, endocrine, respiratory, etc.
* History of myocardial infarction, acute coronary syndromes, coronary angioplasty and/or stenting with in the previous 6 months
* History of another currently active cancer
* History of major surgery within 4 weeks or minor surgery within 1 week
* Other medical or psychiatric illness or organ dysfunction
* HIV positive
* Positive for Hepatitis B surface antigen or Hepatitis C-virus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01351935
Study Brief:
Protocol Section:
NCT01351935