Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
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
2 other identifiers
interventional
102
13 countries
51
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2014
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2014
CompletedFirst Posted
Study publicly available on registry
January 24, 2014
CompletedStudy Start
First participant enrolled
August 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2016
CompletedResults Posted
Study results publicly available
May 11, 2017
CompletedNovember 19, 2018
March 1, 2017
1.7 years
January 22, 2014
March 30, 2017
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).
Secondary Outcomes (6)
Duration of Response
Nodal Response Rate
Complete Response Rate
Progression-Free Survival
Overall Survival
- +1 more secondary outcomes
Study Arms (1)
Idelalisib + rituximab
EXPERIMENTALParticipants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).
Interventions
150 mg tablets administered orally twice daily
375 mg/m\^2 administered intravenously once weekly x 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (56)
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85710, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, 80303, United States
The University of Chicago Medicine
Chicago, Illinois, 60637, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Duke University
Durham, North Carolina, 27705, United States
GHS Cancer Institute
Greenville, North Carolina, 29615, United States
Compass Oncology
Portland, Oregon, 97213, United States
Willamette Valley Cancer Center and Research Institute
Springfield, Oregon, 97477, United States
Hospital of the University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, 2010, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Icon Cancer Foundation
South Brisbane, Queensland, 4101, Australia
St Vincent's Hospital, Melbourne
Fitzroy, Victoria, 3065, Australia
Liverpool Hospital
Liverpool, NSW 2170, Australia
Innsbruck University Hospital, Inner Medicine,
Innsbruck, A-6020, Austria
Univ. Klinik für Innere Medizin III LKH
Salzburg, 5020, Austria
Medizinische Universität Wien, Univ. Klinik f. Innere Med. I, Abteilung für Hämatologie und Hämostaseologie
Vienna, 1090, Austria
AZ Sint-Jan AV Brugge-Oostende
Bruges, 8000, Belgium
University Hospital Leuven
Leuven, 3000, Belgium
University Hospital
Brno, Czechia
Faculty Hospital Hradec Kralove
Hradec Králové, 500 05, Czechia
Hemato-Onkologicka Klinika Fn
Olomuc, Czechia
Faculty hospital Ostrava
Ostrava-Poruba, 70852, Czechia
Faculty Hospital Kralovske Vinohrady
Prague, 10034, Czechia
Vseobecna Fakultim Nemocnice
Prague, 12808, Czechia
Aalborg University Hospital
Aalborg, 9100, Denmark
Centre Hospitalier Universitaire Hôpital Avicenne
Bobigny, 93009, France
CHRU de Lille, Hopital Claude Huriez
Lille, 59037, France
Centre Hospitalier Universitaire Nancy
Nancy, 54511, France
Hopital Pitie-Salpetriere
Paris, 75651, France
University of Debrecen HSC Institute of internal Medicine, Department of Hematology
Debrecen, 4032, Hungary
Institute of Hematology "L. e A. Seràgnoli"
Bologna, 40138, Italy
A.O.Spedali Civili Brescia
Brescia, 25123, Italy
A.O.Niguarda Ca' Granda
Milan, 20162, Italy
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, 41124, Italy
SCDU Medicina II ed Ematologia, A.O.U. San Luigi Gonzaga
Orbassano, 10043, Italy
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-952, Poland
Szpital Specjalistyczny w Brzozowie
Brzozów, 36-200, Poland
Malopolskie Centrum Medyczne s.c.
Krakow, 30-510, Poland
Wojewodzki Szpital Specjalistyczny
Lodz, 93-510, Poland
Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego
Warsaw, 02-781, Poland
Samodzielny Publiczny Szpital Kliniczny
Wroclaw, 50-367, Poland
Centro Hospitalar De Lisboa Norte, E.P.E. - Hospital Santa Maria
Lisbon, 1649-035, Portugal
IPO Porto Francisco Gentil, E.P.E
Porto, 4200-072, Portugal
Emergency County Clinical Hospital Brasov
Brasov, 500326, Romania
Spitalul Clinic Colentina
Bucharest, 20125, Romania
Institutul Regional de Oncologie Iasi
Iași, 700348, Romania
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Clinic
Barcelona, Catalonia, 08036, Spain
Hospital Universitario Puerta De Hierro
Madrid, 28222, Spain
Hospital Clinico Universitario De Valencia (Chuv)
Valencia, 46010, Spain
Saint James's University Hospital
Leeds, LS9 7TF, United Kingdom
Royal Liverpool & Broadgreen Univ. Hospitals
Liverpool, L7 8XP, United Kingdom
University Hospital Southampton NHS Trust
Southampton, 16, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2014
First Posted
January 24, 2014
Study Start
August 6, 2014
Primary Completion
April 27, 2016
Study Completion
May 17, 2016
Last Updated
November 19, 2018
Results First Posted
May 11, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.