Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia



Status:Terminated
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/21/2018
Start Date:February 5, 2014
End Date:June 16, 2016

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia

The primary objective of this study is to evaluate the progression-free survival in
participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise
be suitable for bendamustine and rituximab treatment as standard of care.

An increased rate of deaths and serious adverse events (SAEs) among participants with
front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in
combination with standard therapies was observed by the independent data monitoring committee
(DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data
and terminated this study in agreement with the DMC recommendation and in consultation with
the US Food and Drug Administration (FDA).


Key Inclusion Criteria:

- Documented diagnosis of B-cell CLL, with diagnosis established according to
International Workshop on Chronic Lymphocytic Leukemia (IWCLL)

- No prior therapy for CLL other than corticosteroids for disease complications

- CLL that warrants treatment

- Presence of measurable lymphadenopathy

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Key Exclusion Criteria:

- Known histological transformation from CLL to an aggressive lymphoma (ie, Richter
transformation)

- Known presence of myelodysplastic syndrome

- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of
randomization

- Ongoing liver injury

- History of non-infectious pneumonitis

- Ongoing inflammatory bowel disease

- History of prior allogeneic bone marrow progenitor cell or solid organ transplantation

- Ongoing immunosuppressive therapy other than corticosteroids

- Received last dose of study drug on another therapeutic clinical trial within 30 days
prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
24
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Austin, Texas 78705
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Canton, OH
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Cincinnati, Ohio 45242
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Darlinghurst, New South Wales 2010
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1 St. Francis Drive
Greenville, South Carolina 29601
864-255-1000
Saint Francis Hospital This 245-bed, all-private-room facility is located near downtown Greenville, South Carolina. Formerly...
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Hollywood, Florida
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Indianapolis, IN
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Jacksonville, Florida 32256
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La Jolla, California 92093
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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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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Salt Lake City, Utah 84106
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Santa Maria, California 93454
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Sarasota, Florida 34232
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230 Nebraska St.
Sioux City, Iowa 51101
712-252-0088
Siouxland Hematology-Oncology Associates, LLP Siouxland Hematology-Oncology Associates (SHOA) provides medical oncology treatment. In addition to...
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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