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
Completed · Phase 3
Conditions studied: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
In brief
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.
Key facts
- Study ID
- NCT03406156
- Run by
- AbbVie
- People needed
- 120
- Starts
- 2018-08-10
- Expected to finish
- 2023-07-12
- Last updated by the study team
- 2024-08-06
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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