Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
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 evalu...
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 st...
Eligibility Criteria
Inclusion
- Adequate hematology, kidney and liver function as described in the protocol
- Diagnosis of previously untreated 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/SLL 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
- 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
Key Trial Info
Start Date :
August 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03406156
Start Date
August 10 2018
End Date
July 12 2023
Last Update
August 6 2024
Active Locations (15)
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1
Arizona Oncology Associates, PC-HOPE /ID# 202335
Tempe, Arizona, United States, 85284-1812
2
Rocky Mountain Cancer Centers - Denver Midtown /ID# 202328
Denver, Colorado, United States, 80218
3
MidAmerica Division, Inc. /ID# 201099
Kansas City, Missouri, United States, 64132
4
Oncology Hematology Care, Inc. /ID# 202397
Cincinnati, Ohio, United States, 45236-2725