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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
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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
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Secondary ID [1]
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2013-003314-41
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Secondary ID [2]
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GS-US-312-0133
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response Rate
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Assessment method [1]
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Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).
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Timepoint [1]
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Secondary outcome [1]
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Duration of Response
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Assessment method [1]
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Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.
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Timepoint [1]
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Secondary outcome [2]
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Nodal Response Rate
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Assessment method [2]
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Nodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.
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Timepoint [2]
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Secondary outcome [3]
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Complete Response Rate
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Assessment method [3]
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Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
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Timepoint [3]
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Secondary outcome [4]
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Progression-Free Survival
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Assessment method [4]
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Progression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an IRC.
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Timepoint [4]
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Secondary outcome [5]
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Overall Survival
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Assessment method [5]
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Overall survival was defined as the interval from the start of study treatment to death from any cause.
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Timepoint [5]
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Secondary outcome [6]
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Minimal Residual Disease Negativity Rate at Week 36
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Assessment method [6]
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Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD \< 10\^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.
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Timepoint [6]
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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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/08/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/05/2016
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Sample size
Target
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Accrual to date
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Final
102
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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St Vincent's Hospital, Sydney - Darlinghurst
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St George Hospital - Kogarah
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Icon Cancer Foundation - South Brisbane
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St Vincent's Hospital, Melbourne - Fitzroy
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Liverpool Hospital - Liverpool
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2010 - Darlinghurst
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2217 - Kogarah
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4101 - South Brisbane
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3065 - Fitzroy
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NSW 2170 - Liverpool
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Recruitment outside Australia
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United States of America
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (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 those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
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Trial website
https://clinicaltrials.gov/study/NCT02044822
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Gilead Study Director
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Address
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Gilead Sciences
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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When will data be available (start and end dates)?
18 months after study completion
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Available to whom?
A secured external environment with username, password, and RSA code.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://www.gilead.com/research/disclosure-and-transparency
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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