Previously Untreated CLL and SLL: Safety and Efficacy of Venetoclax in Combination with Obinutuzumab or Ibrutinib in Japanese Subjects
- Conditions
- Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)
- Registration Number
- JPRN-jRCT2021210055
- Lead Sponsor
- Okubo Sumiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Adult male or female, at least 65 years old; or 20 to 64 years old and have at least 1 of the following:
-- Cumulative Illness Rating Scale (CIRS) score > 6.
-- Creatinine clearance (CrCl) estimated < 70 mL/min using Cockcroft-Gault equation.
- Must have measurable nodal disease (by computed tomography [CT]), defined as at least one lymph node
> 1.5 cm in longest diameter.
- Diagnosed Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) that
requires treatment according to the Modified 2008 International Workshop on Chronic Lymphocytic
Leukemia (iwCLL) criteria
- Transformation of Chronic Lymphocytic Leukemia (CLL) to aggressive non-Hodgkin lymphoma (NHL;
Richter's transformation or pro-lymphocyticleukemia).
- Previous treatment history for CLL/SLL.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method