Clinical trial NCT02044822: Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion
Keywords: Chronic Lymphocytic Leukemia
CLL
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-01-24
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Response Rate
Secondary outcomes:
measure: Duration of Response
measure: Nodal Response Rate
measure: Complete Response Rate
measure: Progression-Free Survival
measure: Overall Survival
measure: Minimal Residual Disease Negativity Rate at Week 36
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Chicago
country: United States
facility: The University of Chicago Medicine
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greenville
country: United States
facility: GHS Cancer Institute
state: North Carolina
city: Portland
country: United States
facility: Compass Oncology
state: Oregon
city: Springfield
country: United States
facility: Willamette Valley Cancer Center and Research Institute
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania, Abramson Cancer Center
state: Pennsylvania
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital, Sydney
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Icon Cancer Foundation
state: Queensland
city: Fitzroy
country: Australia
facility: St Vincent's Hospital, Melbourne
state: Victoria
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Innsbruck
country: Austria
facility: Innsbruck University Hospital, Inner Medicine,
city: Salzburg
country: Austria
facility: Univ. Klinik für Innere Medizin III LKH
city: Vienna
country: Austria
facility: Medizinische Universität Wien, Univ. Klinik f. Innere Med. I, Abteilung für Hämatologie und Hämostaseologie
city: Brugge
country: Belgium
facility: AZ Sint-Jan AV Brugge-Oostende
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Brno
country: Czechia
facility: University Hospital
city: Hradec Kralove
country: Czechia
facility: Faculty Hospital Hradec Kralove
city: Olomuc
country: Czechia
facility: Hemato-Onkologicka Klinika Fn
city: Ostrava-Poruba
country: Czechia
facility: Faculty hospital Ostrava
city: Prague 10
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady
city: Praha
country: Czechia
facility: Vseobecna Fakultim Nemocnice
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Bobigny
country: France
facility: Centre Hospitalier Universitaire Hôpital Avicenne
city: Lille
country: France
facility: CHRU de Lille, Hopital Claude Huriez
city: Nancy
country: France
facility: Centre Hospitalier Universitaire Nancy
city: Paris cedex 13
country: France
facility: Hopital Pitie-Salpetriere
city: Debrecen
country: Hungary
facility: University of Debrecen HSC Institute of internal Medicine, Department of Hematology
city: Bologna
country: Italy
facility: Institute of Hematology "L. e A. Seràgnoli"
city: Brescia
country: Italy
facility: A.O.Spedali Civili Brescia
city: Milan
country: Italy
facility: A.O.Niguarda Ca' Granda
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico di Modena
city: Orbassano
country: Italy
facility: SCDU Medicina II ed Ematologia, A.O.U. San Luigi Gonzaga
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne s.c.
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny
city: Lisbon
country: Portugal
facility: Centro Hospitalar De Lisboa Norte, E.P.E. - Hospital Santa Maria
city: Porto
country: Portugal
facility: IPO Porto Francisco Gentil, E.P.E
city: Brasov
country: Romania
facility: Emergency County Clinical Hospital Brasov
city: Bucharest
country: Romania
facility: Spitalul Clinic Colentina
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Cataluña
city: Madrid
country: Spain
facility: Hospital Universitario Puerta De Hierro
city: Valencia
country: Spain
facility: Hospital Clinico Universitario De Valencia (Chuv)
city: Leeds
country: United Kingdom
facility: Saint James's University Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool & Broadgreen Univ. Hospitals
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: