Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 3b 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
Study ID: NCT03406156
Study Description
Brief Summary: This is a multi-cohort, open-label study in previously untreated participants with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), excluding those with the 17p deletion, to evaluate a debulking strategy that would enable all participants to receive subsequent venetoclax as outpatients, with lower risk of tumor lysis syndrome.
Detailed 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates, PC-HOPE /ID# 202335, Tempe, Arizona, United States
Rocky Mountain Cancer Centers - Denver Midtown /ID# 202328, Denver, Colorado, United States
MidAmerica Division, Inc. /ID# 201099, Kansas City, Missouri, United States
Oncology Hematology Care, Inc. /ID# 202397, Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research Center /ID# 201201, Eugene, Oregon, United States
Prisma Health Cancer Inst - Eastside /ID# 202329, Greenville, South Carolina, United States
Tennessee Oncology - Chattanooga /ID# 202840, Chattanooga, Tennessee, United States
Tennessee Oncology-Nashville Centennial /ID# 201098, Nashville, Tennessee, United States
Texas Oncology - Austin Midtown /ID# 201199, Austin, Texas, United States
Texas Oncology - Beaumont /ID# 202359, Beaumont, Texas, United States
Texas Oncology - Medical City Dallas /ID# 201196, Dallas, Texas, United States
Texas Oncology - McAllen /ID# 202331, McAllen, Texas, United States
Texas Oncology - San Antonio Medical Center /ID# 202332, San Antonio, Texas, United States
Texas Oncology - Northeast Texas /ID# 201211, Tyler, Texas, United States
Northwest Cancer Specialists, P.C. /ID# 201198, Vancouver, Washington, United States
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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