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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

120

Study ID:

NCT03406156

Recruitment Status:

Active, not recruiting

Sponsor:

AbbVie

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 15 Locations for this study

See Locations Near You

Arizona Oncology Associates, PC-HOPE /ID# 202335
Tempe Arizona, 85284, United States
Rocky Mountain Cancer Centers - Denver Midtown /ID# 202328
Denver Colorado, 80218, United States
MidAmerica Division, Inc. /ID# 201099
Kansas City Missouri, 64132, United States
Oncology Hematology Care, Inc. /ID# 202397
Cincinnati Ohio, 45236, United States
Willamette Valley Cancer Institute and Research Center /ID# 201201
Eugene Oregon, 97401, United States
Prisma Health Cancer Inst - Eastside /ID# 202329
Greenville South Carolina, 29615, United States
Tennessee Oncology - Chattanooga /ID# 202840
Chattanooga Tennessee, 37404, United States
Tennessee Oncology-Nashville Centennial /ID# 201098
Nashville Tennessee, 37203, United States
Texas Oncology - Austin Midtown /ID# 201199
Austin Texas, 78705, United States
Texas Oncology - Beaumont /ID# 202359
Beaumont Texas, 77701, United States
Texas Oncology - Medical City Dallas /ID# 201196
Dallas Texas, 75230, United States
Texas Oncology - McAllen /ID# 202331
McAllen Texas, 78503, United States
Texas Oncology - San Antonio Medical Center /ID# 202332
San Antonio Texas, 78240, United States
Texas Oncology - Northeast Texas /ID# 201211
Tyler Texas, 75702, United States
Northwest Cancer Specialists, P.C. /ID# 201198
Vancouver Washington, 98684, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

120

Study ID:

NCT03406156

Recruitment Status:

Active, not recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.