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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02044822




Registration number
NCT02044822
Ethics application status
Date submitted
22/01/2014
Date registered
24/01/2014

Titles & IDs
Public title
Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
Scientific 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
Secondary ID [1] 0 0
2013-003314-41
Secondary ID [2] 0 0
GS-US-312-0133
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

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

Experimental: Idelalisib + rituximab - Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).


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

Treatment: Drugs: Rituximab
375 mg/m\^2 administered intravenously once weekly x 8 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Duration of Response
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Nodal Response Rate
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Complete Response Rate
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Progression-Free Survival
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Overall Survival
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Minimal Residual Disease Negativity Rate at Week 36
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
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
6/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/05/2016
Sample size
Target
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital, Sydney - Darlinghurst
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Icon Cancer Foundation - South Brisbane
Recruitment hospital [4] 0 0
St Vincent's Hospital, Melbourne - Fitzroy
Recruitment hospital [5] 0 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
NSW 2170 - Liverpool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Illinois
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United States of America
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Missouri
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United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Pennsylvania
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Austria
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Innsbruck
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Austria
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Salzburg
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Austria
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Vienna
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Belgium
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Brugge
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Belgium
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Leuven
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Olomuc
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Czechia
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Ostrava-Poruba
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Czechia
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Prague 10
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Czechia
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Praha
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Denmark
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Aalborg
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France
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Bobigny
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France
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Lille
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France
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Nancy
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France
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Paris cedex 13
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Hungary
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Debrecen
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Milan
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Italy
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Modena
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Italy
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Orbassano
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Poland
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Pomorskie
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Poland
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Brzozow
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Warszawa
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Poland
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Wroclaw
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Portugal
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Lisbon
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Portugal
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Porto
Country [39] 0 0
Romania
State/province [39] 0 0
Brasov
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Romania
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Bucharest
Country [41] 0 0
Romania
State/province [41] 0 0
Iasi
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Spain
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Cantabria
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Spain
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Cataluña
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Spain
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Madrid
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Spain
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Valencia
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United Kingdom
State/province [46] 0 0
Leeds
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United Kingdom
State/province [47] 0 0
Liverpool
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United Kingdom
State/province [48] 0 0
Southampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
18 months after study completion
Available to whom?
A secured external environment with username, password, and RSA code.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.gilead.com/research/disclosure-and-transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02044822