Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion



Status:Terminated
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/21/2018
Start Date:August 6, 2014
End Date:May 17, 2016

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A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

The primary objective of this study is to evaluate overall response rate (ORR) following
treatment with idelalisib plus rituximab in participants with previously untreated chronic
lymphocytic leukemia (CLL) with 17p deletion.

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 those studies in agreement with the DMC recommendation and in consultation
with the US Food and Drug Administration (FDA). All front-line studies of idelalisib,
including this study, were also terminated.


Key Inclusion Criteria:

- Documented diagnosis of B-cell CLL, according to International Workshop on Chronic
Lymphocytic Leukemia 2008

- Presence of 17p deletion in CLL cells as demonstrated by fluorescence in-situ
hybridization (FISH) testing

- 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

- History of a non-CLL malignancy except for the following:

- the malignancy has been in remission without treatment for ≥ 5 years prior to
enrollment, or

- carcinoma in situ of the cervix, or

- adequately treated basal or squamous cell skin cancer or other localized
non-melanoma skin cancer, or

- asymptomatic prostate cancer without known metastatic disease and with no current
requirement for therapy or requiring only hormonal therapy and with normal
prostate specific antigen for ≥ 1 year prior to enrollment, or

- ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or

- other adequately treated Stage 1 or 2 cancer currently in complete remission

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

- Ongoing liver injury

- History of noninfectious 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 enrollment

- Prior or ongoing clinically significant illness, medical condition, surgical history,
physical finding, electrocardiogram (ECG) finding, or laboratory abnormality

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
12
sites
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Chicago, Illinois 60637
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Darlinghurst, New South Wales 2010
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Greenville, North Carolina 29615
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Niles, Illinois 60714
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Portland, Oregon 97213
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Whittier, California 90603
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