Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
NCT ID: NCT02044822
Last Updated: 2018-11-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
102 participants
INTERVENTIONAL
2014-08-06
2016-05-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Idelalisib + rituximab
Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).
Idelalisib
150 mg tablets administered orally twice daily
Rituximab
375 mg/m\^2 administered intravenously once weekly x 8 weeks
Interventions
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Idelalisib
150 mg tablets administered orally twice daily
Rituximab
375 mg/m\^2 administered intravenously once weekly x 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Innovative Clinical Research Institute
Whittier, California, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, United States
The University of Chicago Medicine
Chicago, Illinois, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Washington University School of Medicine
St Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
GHS Cancer Institute
Greenville, North Carolina, United States
Compass Oncology
Portland, Oregon, United States
Willamette Valley Cancer Center and Research Institute
Springfield, Oregon, United States
Hospital of the University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Icon Cancer Foundation
South Brisbane, Queensland, Australia
St Vincent's Hospital, Melbourne
Fitzroy, Victoria, Australia
Liverpool Hospital
Liverpool, , Australia
Innsbruck University Hospital, Inner Medicine,
Innsbruck, , Austria
Univ. Klinik für Innere Medizin III LKH
Salzburg, , Austria
Medizinische Universität Wien, Univ. Klinik f. Innere Med. I, Abteilung für Hämatologie und Hämostaseologie
Vienna, , Austria
AZ Sint-Jan AV Brugge-Oostende
Bruges, , Belgium
University Hospital Leuven
Leuven, , Belgium
University Hospital
Brno, , Czechia
Faculty Hospital Hradec Kralove
Hradec Králové, , Czechia
Hemato-Onkologicka Klinika Fn
Olomuc, , Czechia
Faculty hospital Ostrava
Ostrava-Poruba, , Czechia
Faculty Hospital Kralovske Vinohrady
Prague, , Czechia
Vseobecna Fakultim Nemocnice
Prague, , Czechia
Aalborg University Hospital
Aalborg, , Denmark
Centre Hospitalier Universitaire Hôpital Avicenne
Bobigny, , France
CHRU de Lille, Hopital Claude Huriez
Lille, , France
Centre Hospitalier Universitaire Nancy
Nancy, , France
Hopital Pitie-Salpetriere
Paris, , France
University of Debrecen HSC Institute of internal Medicine, Department of Hematology
Debrecen, , Hungary
Institute of Hematology "L. e A. Seràgnoli"
Bologna, , Italy
A.O.Spedali Civili Brescia
Brescia, , Italy
A.O.Niguarda Ca' Granda
Milan, , Italy
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, , Italy
SCDU Medicina II ed Ematologia, A.O.U. San Luigi Gonzaga
Orbassano, , Italy
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Szpital Specjalistyczny w Brzozowie
Brzozów, , Poland
Malopolskie Centrum Medyczne s.c.
Krakow, , Poland
Wojewodzki Szpital Specjalistyczny
Lodz, , Poland
Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego
Warsaw, , Poland
Samodzielny Publiczny Szpital Kliniczny
Wroclaw, , Poland
Centro Hospitalar De Lisboa Norte, E.P.E. - Hospital Santa Maria
Lisbon, , Portugal
IPO Porto Francisco Gentil, E.P.E
Porto, , Portugal
Emergency County Clinical Hospital Brasov
Brasov, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Institutul Regional de Oncologie Iasi
Iași, , Romania
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Clinic
Barcelona, Catalonia, Spain
Hospital Universitario Puerta De Hierro
Madrid, , Spain
Hospital Clinico Universitario De Valencia (Chuv)
Valencia, , Spain
Saint James's University Hospital
Leeds, , United Kingdom
Royal Liverpool & Broadgreen Univ. Hospitals
Liverpool, , United Kingdom
University Hospital Southampton NHS Trust
Southampton, , United Kingdom
Countries
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Other Identifiers
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2013-003314-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-312-0133
Identifier Type: -
Identifier Source: org_study_id
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