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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01732926




Registration number
NCT01732926
Ethics application status
Date submitted
14/11/2012
Date registered
26/11/2012
Date last updated
16/11/2018

Titles & IDs
Public title
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Secondary ID [1] 0 0
2012-004034-42
Secondary ID [2] 0 0
GS-US-313-0125
Universal Trial Number (UTN)
Trial acronym
Bridalveil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Indolent Non-Hodgkin's Lymphomas 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Idelalisib
Treatment: Drugs - Rituximab
Treatment: Drugs - Bendamustine
Treatment: Drugs - Placebo

Experimental: Rituximab + Bendamustine + Idelalisib - Participants will receive rituximab + bendamustine + idelalisib.

Experimental: Rituximab + Bendamustine + Placebo - Participants will receive rituximab + bendamustine + placebo.


Treatment: Drugs: Idelalisib
150 mg tablet administered orally twice daily

Treatment: Drugs: Rituximab
375 mg/m\^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)

Treatment: Drugs: Bendamustine
90 mg/m\^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)

Treatment: Drugs: Placebo
Tablet administered orally twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Complete Response Rate (CR)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Lymph Node Response Rate
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
Key

* Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following

1. Follicular lymphoma (FL) Grade 1, 2, or 3a
2. Small lymphocytic lymphoma (SLL)
3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.
* Prior treatment with bendamustine that was not effective.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/05/2016
Sample size
Target
Accrual to date
Final
475
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Haematology and Oncology Clinics of Australia Gold Coast - South Brisbane
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
Saint Vincent's Hospital - Fitzroy
Recruitment hospital [8] 0 0
Western Hospital - Footscray
Recruitment hospital [9] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3011 - Footscray
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Kansas
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New York
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Ohio
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South Carolina
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Texas
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Washington
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Wisconsin
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Alberta
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British Columbia
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Nova Scotia
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Ontario
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Canada
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Quebec
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Canada
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Winnipeg
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Czechia
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Severomoravsky KRAJ
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Czechia
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Brno
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Czechia
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Hradec Králové
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France
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Alsace
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Aquitaine
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France
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Haute-normandie
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France
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Ile-de-france
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France
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PAYS DE LA Loire
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France
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Rhone-alpes
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France
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Brest Cedex
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France
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Dunkerque
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France
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La Roche sur Yon
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France
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Lyon Cedex 08
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France
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Marseille
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France
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Nantes cedex 1
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France
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Poitiers Cedex
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France
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Tours
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France
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Villejuif
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Germany
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Baden-wuerttemberg
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Germany
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Hessen
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Germany
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Berlin
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Germany
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München
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Israel
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Ashkelon
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Aviano
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Bologna
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Brescia
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Genova
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Milano
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Novara
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Pesaro
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Piacenza
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Siena
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Torino
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Korea, Republic of
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Busan
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Seoul
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Poland
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Gdansk
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Kraków
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Lublin
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Lódz
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Olsztyn
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Slupsk
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Warszawa
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Russian Federation
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Ekaterinburg
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Volgograd
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Spain
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Madrid
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Spain
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Badalona
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Spain
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Salamanca
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Spain
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San Cristobal de La Laguna
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Stockholm
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Sweden
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Jönköping
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Taiwan
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Changhua city
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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United Kingdom
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England
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United Kingdom
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Middlesex
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United Kingdom
State/province [88] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/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).
Trial website
https://clinicaltrials.gov/study/NCT01732926
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01732926