A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539512
• Other study ID #: GS-US-312-0116
• Secondary ID: 2011-005180-24
• Status: Completed
• Phase: Phase 3
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion:

• Adult subjects with previously treated recurrent CLL who have measurable lymphadenopathy

• Require therapy for CLL

• Have experienced CLL progression < 24 months since the completion of the last prior therapy

• Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Idelalisib
Idelalisib 150 mg tablet administered orally twice daily
• Rituximab
Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter
• Placebo to match idelalisib
Placebo to match idelalisib administered orally twice daily

Locations

Country	Name	City	State
France	Hôpital Henri Mondor	Creteil
France	Centre Hospitalier Régional Universitaire de Lille (CHRU)	Lille
France	Hôpital Emile Muller	Mulhouse
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	Hôpital Pontchaillou	Rennes
France	Centre Henri Becquerel	Rouen
France	Hopital Purpan	Toulouse
Germany	Gemeinschaftspraxis Hämatologie-Onkologie	Dresden
Germany	Internistische Gemeinschaftspraxis	Erlangen
Germany	Universitätsklinikum Köln	Köln
Germany	Stauferklinikum Schwäb. Gmünd	Mutlangen
Germany	Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth	Neunkirchen
Germany	Universitätsklinikum Ulm	Ulm
Italy	Ospedale Oncologico Regionale A. Businco	Cagliari
Italy	Ospedale San Raffaele S.r.l.	Milano
Italy	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Torino
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	Castle Hill Hospital	Cottingham
United Kingdom	Dorset County Hospital	Dorchester
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Northwick Park Hospital	Harrow
United Kingdom	St James's University Hospital	Leeds
United Kingdom	Royal Liverpool University Hospital	Liverpool
United Kingdom	Hammersmith Hospital	London
United Kingdom	King's College Hospital	London
United Kingdom	Sarah Cannon Research Institute UK	London
United Kingdom	Freeman Hospital	Newcastle upon Tyne
United Kingdom	Princess Royal University Hospital	Orpington
United Kingdom	Salisbury District Hospital	Salisbury
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	Royal Marsden Hospital	Sutton
United Kingdom	Great Western Hospital	Swindon
United Kingdom	Torbay District General Hospital	Torquay
United Kingdom	Royal Cornwall Hospital	Truro
United Kingdom	New Cross Hospital	Wolverhampton
United Kingdom	Yeovil District Hospital	Yeovil
United States	Winship Cancer Institute at Emory University	Atlanta	Georgia
United States	Collaborative Medical Research Corporation	Boynton Beach	Florida
United States	Collaborative Research Group LLC	Boynton Beach	Florida
United States	Northwestern University	Chicago	Illinois
United States	Rocky Mountain Blood and Marrow Transplant Program	Denver	Colorado
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Texas Oncology, P.A.	Fort Worth	Texas
United States	University of Florida	Gainesville	Florida
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	Clearview Cancer Institute	Huntsville	Alabama
United States	University of California, San Diego- Moores Cancer Center	La Jolla	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Hematology Oncology Associates of Northern New Jersey	Morristown	New Jersey
United States	Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Columbia University Medical Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Ventura County Hematology Oncology Specialists	Oxnard	California
United States	Oncology and Hematology Associates of Southwest Virginia, Inc	Roanoke	Virginia
United States	Florida Cancer Specialists	Saint Petersburg	Florida
United States	Cancer Care Network of South Texas	San Antonio	Texas
United States	UCLA	Santa Monica	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Willamette Valley Cancer Center	Springfield	Oregon
United States	Stanford Cancer Center	Stanford	California
United States	Northwest Cancer Specialists, PC	Tualatin	Oregon
United States	Arizona Oncology Associates	Tucson	Arizona
United States	Georgetown University Medical Center Lombardi Cancer Center	Washington	District of Columbia
United States	Yakima Valley Memorial Hospital / North Star Lodge	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival	Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by = 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or = 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.	Up to 17 months
Secondary	Overall Response Rate	Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.; Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.; Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus = 1 of the following: = 1500/µL absolute neutrophil count, > 100000/µL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors.	Up to 17 months
Secondary	Lymph Node Response Rate	Lymph node response rate was defined as the percentage of participants who achieved a = 50% decrease from baseline in the SPD of index lymph nodes.	Up to 17 months
Secondary	Overall Survival	Overall survival was defined as the interval from randomization to death from any cause.	Up to 17 months
Secondary	Complete Response Rate	Complete response rate was defined as the percentage of participants who achieved a complete response.	Up to 17 months