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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02044822
Ethics application status
Date submitted
22/01/2014
Date registered
24/01/2014
Date last updated
19/11/2018

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 - 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).
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Duration of Response - 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.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Nodal Response Rate - 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.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Complete Response Rate - 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.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Progression-Free Survival - 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.
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Overall Survival - Overall survival was defined as the interval from the start of study treatment to death from any cause.
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Minimal Residual Disease Negativity Rate at Week 36 - 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.
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
Gender
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
N/A
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
Austria
State/province [9] 0 0
Innsbruck
Country [10] 0 0
Austria
State/province [10] 0 0
Salzburg
Country [11] 0 0
Austria
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Vienna
Country [12] 0 0
Belgium
State/province [12] 0 0
Brugge
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Czechia
State/province [14] 0 0
Brno
Country [15] 0 0
Czechia
State/province [15] 0 0
Hradec Kralove
Country [16] 0 0
Czechia
State/province [16] 0 0
Olomuc
Country [17] 0 0
Czechia
State/province [17] 0 0
Ostrava-Poruba
Country [18] 0 0
Czechia
State/province [18] 0 0
Prague 10
Country [19] 0 0
Czechia
State/province [19] 0 0
Praha
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Denmark
State/province [20] 0 0
Aalborg
Country [21] 0 0
France
State/province [21] 0 0
Bobigny
Country [22] 0 0
France
State/province [22] 0 0
Lille
Country [23] 0 0
France
State/province [23] 0 0
Nancy
Country [24] 0 0
France
State/province [24] 0 0
Paris cedex 13
Country [25] 0 0
Hungary
State/province [25] 0 0
Debrecen
Country [26] 0 0
Italy
State/province [26] 0 0
Bologna
Country [27] 0 0
Italy
State/province [27] 0 0
Brescia
Country [28] 0 0
Italy
State/province [28] 0 0
Milan
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Italy
State/province [29] 0 0
Modena
Country [30] 0 0
Italy
State/province [30] 0 0
Orbassano
Country [31] 0 0
Poland
State/province [31] 0 0
Pomorskie
Country [32] 0 0
Poland
State/province [32] 0 0
Brzozow
Country [33] 0 0
Poland
State/province [33] 0 0
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
State/province [38] 0 0
Porto
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Romania
State/province [39] 0 0
Brasov
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Romania
State/province [40] 0 0
Bucharest
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Romania
State/province [41] 0 0
Iasi
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Spain
State/province [42] 0 0
Cantabria
Country [43] 0 0
Spain
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Cataluña
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Spain
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Madrid
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Spain
State/province [45] 0 0
Valencia
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United Kingdom
State/province [46] 0 0
Leeds
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Liverpool
Country [48] 0 0
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
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.
Trial website
https://clinicaltrials.gov/show/NCT02044822
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/show/NCT02044822