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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01659021




Registration number
NCT01659021
Ethics application status
Date submitted
3/08/2012
Date registered
7/08/2012

Titles & IDs
Public title
Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
Scientific title
A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
Secondary ID [1] 0 0
2012-001236-65
Secondary ID [2] 0 0
GS-US-312-0119
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 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 - Ofatumumab

Experimental: Idelalisib+ofatumumab - Randomized Initial Therapy (24 weeks): Idelalisib + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation.

Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.

Active comparator: Ofatumumab - Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)

Continuing Therapy/Observation: Observation until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation.

Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.


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

Treatment: Drugs: Ofatumumab
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival
Timepoint [1] 0 0
Randomization to End of Study (up to 60 months)
Secondary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
Randomization to End of Study (up to 60 months)
Secondary outcome [2] 0 0
Lymph Node Response Rate
Timepoint [2] 0 0
Randomization to End of Study (up to 60 months)
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years)
Secondary outcome [4] 0 0
Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation
Timepoint [4] 0 0
Randomization to End of Study (up to 60 months)
Secondary outcome [5] 0 0
Complete Response Rate
Timepoint [5] 0 0
Randomization to End of Study (up to 60 months)

Eligibility
Key inclusion criteria
Key

* Adults 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
* Have disease that is not refractory to ofatumumab

Note: Other protocol defined Inclusion/
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Open (masking not used)
Who is / are masked / blinded?



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
4/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/08/2018
Sample size
Target
Accrual to date
Final
261
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Saint George and Sutherland Hospitals - Kogarah
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Haematology and Oncology Clinics of Australia at Mater - Milton
Recruitment hospital [6] 0 0
Ashford Cancer Centre Research - Ashford
Recruitment hospital [7] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
Frankston Hospital - Melbourne
Recruitment hospital [9] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4064 - Milton
Recruitment postcode(s) [6] 0 0
5035 - Ashford
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3199 - Melbourne
Recruitment postcode(s) [9] 0 0
5011 - Woodville
Recruitment outside Australia
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United States of America
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California
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Colorado
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Florida
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Georgia
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Kentucky
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Massachusetts
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Missouri
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Nevada
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Ohio
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Oregon
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South Carolina
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Tennessee
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Utah
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United States of America
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Washington
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Ghent
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Belgium
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Leuven
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Quebec
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Saskatchewan
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Canada
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Winnipeg
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Aalborg
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Århus
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France
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Aquitaine
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France
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Ile-de-france
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France
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Languedoc-Roussillon
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France
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Limousin, Lorraine
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France
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Midi-pyrenees
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France
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Auvergne
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Ireland
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Cork
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Ireland
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Dublin
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Poland
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Malopolskie
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Pomorskie
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Brzozow
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Lódz
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Warszawa
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Barcelona
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Murcia
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Luleå
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Stockholm
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England
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Norfolk
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Leeds
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London
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United Kingdom
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Oxford

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?




Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT01659021