A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)



Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:March 17, 2014
End Date:June 30, 2022

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A Multicenter, Phase III, Open-Label, Randomized Study in Relapsed/Refractory Patients With Chronic Lymphocytic Leukemia to Evaluate the Benefit of Venetoclax (GDC-0199/ABT-199) Plus Rituximab Compared With Bendamustine Plus Rituximab

The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the
benefit of venetoclax in combination with rituximab compared with bendamustine in combination
with rituximab in participants with relapsed or refractory CLL. Participants will be randomly
assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine +
rituximab (Arm B).


Inclusion Criteria:

- Diagnosis of CLL per diagnostic criteria for relapsed or refractory CLL per the
international workshop on chronic lymphocytic leukemia (iwCLL) guidelines

- Previously treated with 1-3 lines of therapy (example: completed greater than or equal
to [>/=] 2 treatment cycles per therapy), including at least one standard
chemotherapy-containing regimen

- Participants previously treated with bendamustine only if their duration of response
was >/= 24 months

- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to
(
- Adequate bone marrow function

- Adequate renal and hepatic function

- Participants must use effective birth control throughout study until at least 30 days
after study treatment or 1 year after rituximab treatment, whichever is later; female
participants must not be pregnant or breast-feeding

- For participants with the 17p deletion, previously treated with 1-3 lines of therapy,
including at least one prior standard chemotherapy-containing regimen or at least one
prior alemtuzumab-containing therapy

Exclusion Criteria:

- Transformation of CLL to aggressive non-Hodgkin lymphoma or central nervous system
(CNS) involvement by CLL

- Undergone an allogenic stem cell transplant

- A history of significant renal, neurologic, psychiatric, endocrine, metabolic,
immunologic, cardiovascular or hepatic disease

- Hepatitis B or C or known human immunodeficiency virus (HIV) positive

- Receiving warfarin treatment

- Received an anti-CLL monoclonal antibody within 8 weeks prior to the first dose of
study drug

- Received any anti-cancer or investigational therapy within 28 days prior to the first
dose of study drug or has not recovered to less than Grade 2 clinically significant
adverse effect(s)/toxicity(ies) of any previous therapy

- Received cytochrome P450 3A4 (CYP3A4) inhibitors (such as fluconazole, ketoconazole
and clarithromycin) or inducers (such as rifampin, carbamazapine, phenytoin, St.
John's Wort) within 7 days prior to the first dose of venetoclax

- History of prior venetoclax treatment

- Participants with another cancer, history of another cancer considered uncured on in
complete remission for <5 years, or currently under treatment for another suspected
cancer except non-melanoma skin cancer or carcinoma in situ of the cervix that has
been treated or excised and is considered resolved

- Malabsorption syndrome or other condition that precludes enteral route of
administration

- Other clinically significant uncontrolled condition(s) including, but not limited to,
systemic infection (viral, bacterial or fungal)

- Vaccination with a live vaccine within 28 days prior to randomization

- Consumed grapefruit or grapefruit products, seville oranges (including marmalade
containing seville oranges), or star fruit within 3 days prior to the first dose of
study treatment

- A cardiovascular disability status of New York Heart Association Class >/=3. Class 3
is defined as cardiac disease in which participants are comfortable at rest but have
marked limitation of physical activity due to fatigue, palpitations, dyspnea, or
anginal pain

- Major surgery within 30 days prior to the first dose of study treatment

- A participant who is pregnant or breastfeeding

- Known allergy to both xanthine oxidase inhibitors and rasburicase
We found this trial at
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sites
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Cleveland, OH
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3310 Live Oak Street
Dallas, Texas 75204
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Detroit, Michigan 48202
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Harvey, Illinois 60426
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Jacksonville, Florida 32224
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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