Chronic Lymphocytic Leukemia Clinical Trial
A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy
Summary
A study in previously untreated Chronic Lymphocytic Leukemia participants to evaluate alternate administration strategies for induction therapy (debulking) with obinutuzumab or obinutuzumab/bendamustine prior to combination therapy with obinutuzumab and venetoclax.
Full Description
Safety and efficacy data through 13 October 2021 are included in the interim analysis, which was conducted after all participants completed the post-treatment Week 65 visit or discontinued from the study.
Eligibility Criteria
Inclusion Criteria:
Adequate hematology, kidney and liver function as described in the protocol
Diagnosis of previously untreated leukemia-cll/" >chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG) criteria
Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1
CLL requires treatment according to the IWCLL criteria
Medium tumor burden (any lymph node [LN] 5 to < 10 cm OR absolute lymphocyte count [ALC] ≥ 25 × 10^9/L) OR High tumor burden (any LN ≥ 10 cm OR ALC ≥ 25 × 10^9/L and LN ≥ 5 cm)
Exclusion Criteria:
Presence of 17p deletion at Screening
Richter's syndrome (transformation of CLL/SLL to aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma)
Prolymphocytic leukemia
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There are 15 Locations for this study
Tempe Arizona, 85284, United States
Denver Colorado, 80218, United States
Kansas City Missouri, 64132, United States
Cincinnati Ohio, 45236, United States
Eugene Oregon, 97401, United States
Greenville South Carolina, 29615, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78705, United States
Beaumont Texas, 77701, United States
Dallas Texas, 75230, United States
McAllen Texas, 78503, United States
San Antonio Texas, 78240, United States
Tyler Texas, 75702, United States
Vancouver Washington, 98684, United States
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