Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
- Conditions
- Indolent Non-Hodgkin's Lymphomas
- Interventions
- Registration Number
- NCT01732913
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 295
-
Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following:
- Follicular lymphoma (FL) Grade 1, 2, or 3a
- Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10^9/L at the time of diagnosis
- Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
- Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
Key
- History of lymphoid malignancy other than those allowed per inclusion criteria
- Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B , alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
- Received previous treatment with rituximab that was not effective.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rituximab + Placebo Placebo Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily. Rituximab + idelalisib Rituximab Participants will receive rituximab + idelalisib. Rituximab + idelalisib Idelalisib Participants will receive rituximab + idelalisib. Rituximab + Placebo Rituximab Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily. Rituximab + Placebo Idelalisib Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
- Primary Outcome Measures
Name Time Method Progression Free Survival Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).
- Secondary Outcome Measures
Name Time Method Overall Response Rate Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response for participants with Waldenstrom's). ORR was to be assessed by an IRC.
Complete Response Rate Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC.
Lymph Node Response Rate Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.
Overall Survival Overall survival is defined as the interval from randomization to death from any cause.
Trial Locations
- Locations (103)
Cancer Center of Santa Barbara
🇺🇸Santa Barbara, California, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Saint Jude Heritage Healthcare
🇺🇸Fullerton, California, United States
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Ironwood Cancer and Research Center
🇺🇸Chandler, Arizona, United States
City of Hope Cancer Center
🇺🇸Duarte, California, United States
Central Coast Medical Oncology Group
🇺🇸Santa Maria, California, United States
Florida Cancer Specialists and Research Institute
🇺🇸Fort Myers, Florida, United States
Tennessee Oncology, PLLC
🇺🇸Chattanooga, Tennessee, United States
Prairie Lakes Healthcare System
🇺🇸Watertown, South Dakota, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Froedtert Hospital and Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Adelaide Cancer Centre
🇦🇺Kurralta Park, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Australia
Fakultní nemocnice Hradec Králové
🇨🇿Hradec Králové, Czechia
Hôpital Necker-Enfants Malades
🇫🇷Paris, Ile-de-france, France
Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
🇫🇷Poitiers Cedex, France
Gemeinschaftspraxis Dres. Söling Und Siehl
🇩🇪Kassel, Hessen, Germany
Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara
🇮🇹Novara, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
🇮🇹Pesaro, Italy
Osaka City University Hospital
🇯🇵Osaka-shi, Osaka, Japan
Toranomon Hospital
🇯🇵Minato-ku, Tokyo, Japan
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Malopolskie Centrum Medyczne S.C.
🇵🇱Kraków, Poland
Hospital Geral de Santo António do Centro Hospitalar do Porto
🇵🇹Porto, Portugal
Sverdlovsk Regional Clinical Hospital #1
🇷🇺Ekaterinburg, Russian Federation
Saint Petersburg I.P. Pavlov State Medical University
🇷🇺Saint-Petersburg, Russian Federation
Saratov State Medical University
🇷🇺Saratov, Russian Federation
FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies"
🇷🇺Saint Petersburg, Russian Federation
Singapore General Hospital
🇸🇬Singapore, Singapore
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
Skånes Universitetssjukhus, Malmö
🇸🇪Malmö, Sweden
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Cancer Care Associates
🇺🇸Redondo Beach, California, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Signal Point Clinical Research Center, LLC
🇺🇸Middletown, Ohio, United States
Center for Cancer and Blood Disorders, PC
🇺🇸Fort Worth, Texas, United States
Texas Oncology, P.A.
🇺🇸Bedford, Texas, United States
Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Shenandoah Oncology Associates, PC
🇺🇸Winchester, Virginia, United States
Northwest Medical Specialties, PLLC
🇺🇸Tacoma, Washington, United States
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Centre Hospitalier Lyon Sud
🇫🇷Pierre Bénite Cedex, France
Mount Vernon Hospital
🇬🇧Middlesex, United Kingdom
Sunderland Royal Infirmary
🇬🇧Sunderland, United Kingdom
Hôpital Hôtel-Dieu
🇫🇷Nantes cedex 1, France
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
University Hospital of Bordeaux
🇫🇷Pessac, Aquitaine, France
Centre Hospitalier Universitaire Brest
🇫🇷Brest, France
Centre Hospitalier de Dunkerque
🇫🇷Dunkerque, France
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
🇫🇷Lille cedex, NORD Pas-de-calais, France
Debreceni Egyetem Orvos-és Egészségtudományi Centrum
🇭🇺Debrecen, Hajdu-bihar, Hungary
Hadassah Medical Organization, Ein Kerem
🇮🇱Jerusalem, Israel
Országos Onkológiai Intézet
🇭🇺Budapest, Hungary
Saint Vincent's Hospital
🇦🇺Fitzroy, Victoria, Australia
Centre Hospitalier de Versailles
🇫🇷Le Chesnay, France
Okayama University Hospital
🇯🇵Okayama-city, Okayama, Japan
Gleneagles Medical Centre
🇸🇬Singapore, Singapore
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Centre Léon Bérard
🇫🇷Lyon Cedex 08, France
Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
Somogy Megyei Kaposi Mór Oktató Kórház
🇭🇺Kaposvár, Somogy, Hungary
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
🇩🇪Villingen-Schwenningen, Baden-wuerttemberg, Germany
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Azienda Ospedaliera Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Nagoya City University Hospital
🇯🇵Nagoya City, Aichi, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe-city, Hyogo, Japan
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Middlesex Hospital Cancer Center
🇺🇸Middletown, Connecticut, United States
Haematology and Oncology Clinics of Australia at Chermside
🇦🇺Milton, Queensland, Australia
Aichi Cancer Center Hospital
🇯🇵Nagoya, Aichi, Japan
Markusovszky Egyetemi Oktatókórház
🇭🇺Szombathely, VAS, Hungary
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
🇮🇹Bologna, Italy
The Cancer Institute Hospital of JFCR
🇯🇵Koto-ku, Tokyo, Japan
Institutul Clinic Fundeni
🇷🇴Bucuresti, Romania
Chang Gung Memorial Hospital (CGMH)
🇨🇳Kaohsiung, Taiwan
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Centro di Riferimento Oncologico di Aviano
🇮🇹Pordenone, Italy
National Hospital Organization Kyushu Cancer Center
🇯🇵Minami Ku, Fukuoka, Japan
Tokai University Hospital
🇯🇵Isehara-shi, Kanagawa, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
🇵🇱Olsztyn, Poland
Centrum Onkologii i Hipertermii
🇵🇱Warszawa, Poland
Ryazan Regional Clinical Hospital
🇷🇺Ryazan, Russian Federation
Barts and The London NHS Trust
🇬🇧London, England, United Kingdom
National Hospital Organization Nagoya Medical Center
🇯🇵Nagoya-shi, Aichi, Japan
National Hospital Organization Kumamoto Medical Center
🇯🇵Chuo-ku, Kumamoto, Japan
Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko
🇷🇺Nizhniy Novgorod, Russian Federation
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Western Hospital
🇦🇺Footscray, Victoria, Australia
Montefiore Medical Center
🇺🇸Bronx, New York, United States