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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02536300




Registration number
NCT02536300
Ethics application status
Date submitted
27/08/2015
Date registered
31/08/2015
Date last updated
3/05/2019

Titles & IDs
Public title
Dose Optimization Study of Idelalisib in Follicular Lymphoma
Scientific title
Dose Optimization Study of Idelalisib in Follicular Lymphoma
Secondary ID [1] 0 0
2015-000366-66
Secondary ID [2] 0 0
GS-US-313-1580
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma 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

Experimental: Idelalisib 150 mg Continuously - Participants will receive idelalisib 150 mg twice daily continuously.
For participants enrolled prior to protocol amendment 5: Based on the independent review committee (IRC) response assessment, participants may be discontinued from the study or may receive blinded or open-label idelalisib 150 mg twice daily.

Experimental: Idelalisib 100 mg - Participants will receive idelalisib 100 mg twice daily continuously. Based on the IRC response assessment, participants may either be dose escalated to open-label 150 mg twice daily or maintain blind and continue on idelalisib 100 mg twice daily.
As of protocol amendment 5, enrollment to this arm has been closed.

Experimental: Idelalisib 150 mg 28-Day Cycles - Participants will receive idelalisib 150 mg twice daily in 28-day cycles with 21 days on-treatment and 7 days off-treatment.


Treatment: Drugs: Idelalisib
Idelalisib tablet administered orally

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

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) - ORR is defined as the proportion of participants who achieve a partial response (PR) or complete response (CR).
Timepoint [1] 0 0
Up to end of radiographic assessment (approximately Week 84)
Primary outcome [2] 0 0
Incidence of Grade = 4 Treatment-Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to end of study (approximately 10 years)
Secondary outcome [1] 0 0
Duration of Response (DOR) - DOR is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression by IRC or death from any cause.
Timepoint [1] 0 0
Up to end of radiographic assessment (approximately Week 84)
Secondary outcome [2] 0 0
Overall Response Rate by Week 24 - ORR by Week 24 is defined as the proportion of participants who achieve a PR or CR by Week 24.
Timepoint [2] 0 0
Up to Week 24
Secondary outcome [3] 0 0
Overall Safety Profile of Idelalisib - The overall safety profile of idelalisib will include the incidence of adverse events (AE), clinically significant laboratory abnormalities, = Grade 3 AEs, idelalisib-related AEs, serious adverse events (SAEs), and AEs leading to interruption, reduction, or discontinuation of idelalisib.
Timepoint [3] 0 0
Up to end of study (approximately 10 years)
Secondary outcome [4] 0 0
Time to onset of adverse events of interest (AEI) - Time to onset of AEI is defined as the interval from the start of idelalisib treatment to the first documentation of start of AEI.
Timepoint [4] 0 0
Up to end of study (approximately 10 years)
Secondary outcome [5] 0 0
Progression-Free Survival (PFS) - PFS is defined as the interval from randomization to the earlier of the first documentation of disease progression by IRC or death from any cause.
Timepoint [5] 0 0
Up to end of radiographic assessment (approximately Week 84)
Secondary outcome [6] 0 0
Overall Survival (OS) - OS is defined as the interval from randomization to death from any cause.
Timepoint [6] 0 0
Up to end of study (approximately 10 years)
Secondary outcome [7] 0 0
Idelalisib Trough (pre-dose) and Peak (1.5-hour samples) Plasma Concentrations
Timepoint [7] 0 0
Predose and 1.5 hours postdose in the morning up to Week 48

Eligibility
Key inclusion criteria
Key

- Histologically confirmed diagnosis of B-cell follicular lymphoma (FL), and grade
limited to 1, 2, or 3a based on criteria established by the WHO 2008 classification of
tumors of hematopoietic and lymphoid tissues

- Relapsed or refractory FL and have received at least 2 lines of prior therapy for FL
and have no other therapeutic options

- Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease per Lugano Classification
Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined
as the presence of = 1 lesion that measures = 1.5 cm in the longest dimension (LD) and
= 1.0 cm in the longest perpendicular dimension (LPD) as assessed by positron emission
tomography-computed tomography (PET-CT), computed tomography (CT) or magnetic
resonance imaging (MRI)

- Required baseline central laboratory data in protocol.

- For female individuals of childbearing potential and male individuals of reproductive
potential, willingness to use a protocol- recommended method of contraception

- Lactating females must agree to discontinue nursing

- Willing and able to comply with scheduled visits, drug administration plan, imaging
studies, laboratory tests, other study procedures, and study restrictions including
mandatory prophylaxis for Pneumocystis jirovecii pneumonia (PJP)

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of lymphoid malignancy other than FL (eg, diffuse large B-cell lymphoma)

- Known history of, or clinically apparent, central nervous system (CNS) lymphoma or
leptomeningeal lymphoma.

- Known presence of intermediate- or high-grade myelodysplastic syndrome.

- Known history of serious allergic reaction including anaphylaxis or Stevens- Johnson
syndrome/ toxic epidermal necrolysis

- History of a non-lymphoid malignancy except for protocol allowed exceptions

- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of
enrollment

- Known history of drug-induced liver injury, chronic active hepatitis B virus (HBV),
chronic active hepatitis C virus (HCV), alcoholic liver disease, non-alcoholic
steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary
cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis

- History of or ongoing drug-induced pneumonitis

- History of or ongoing inflammatory bowel disease

- Known human immunodeficiency virus (HIV) infection

- History of prior allogeneic bone marrow progenitor cell or solid organ transplantation

- Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg
prednisone or equivalent/day) with the exception of the use of topical, enteric, or
inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for
autoimmune anemia and/or thrombocytopenia

- Concurrent participation in another therapeutic clinical trial

- Prior treatment with phosphatidylinositol 3-kinase (PI3K) inhibitors

- Cytomegalovirus (CMV)- Ongoing infection, treatment, or prophylaxis within 28 days
prior to the Screening Visit CMV test

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
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
Active, not recruiting
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,SA
Recruitment hospital [1] 0 0
St Vincent's Public Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Calvary Hospital - North Adelaide
Recruitment hospital [3] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- North Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Idaho
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Czechia
State/province [7] 0 0
Brno
Country [8] 0 0
Czechia
State/province [8] 0 0
Praha
Country [9] 0 0
France
State/province [9] 0 0
Argenteuil
Country [10] 0 0
France
State/province [10] 0 0
Avignon
Country [11] 0 0
France
State/province [11] 0 0
Le Mans
Country [12] 0 0
France
State/province [12] 0 0
Paris Cedex 12
Country [13] 0 0
France
State/province [13] 0 0
Pierre Bénite Cedex
Country [14] 0 0
France
State/province [14] 0 0
Poitiers Cedex
Country [15] 0 0
France
State/province [15] 0 0
Tours
Country [16] 0 0
Israel
State/province [16] 0 0
Haifa
Country [17] 0 0
Israel
State/province [17] 0 0
Kfar Saba
Country [18] 0 0
Italy
State/province [18] 0 0
Bergamo
Country [19] 0 0
Italy
State/province [19] 0 0
Brescia
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
Italy
State/province [21] 0 0
Palermo
Country [22] 0 0
Italy
State/province [22] 0 0
Torino
Country [23] 0 0
Italy
State/province [23] 0 0
Udine
Country [24] 0 0
Poland
State/province [24] 0 0
Brzozow
Country [25] 0 0
Poland
State/province [25] 0 0
Gdynia
Country [26] 0 0
Poland
State/province [26] 0 0
Kraków
Country [27] 0 0
Poland
State/province [27] 0 0
Lublin
Country [28] 0 0
Poland
State/province [28] 0 0
Warszawa
Country [29] 0 0
Poland
State/province [29] 0 0
Wroclaw
Country [30] 0 0
Romania
State/province [30] 0 0
Baia Mare
Country [31] 0 0
Romania
State/province [31] 0 0
Bucuresti
Country [32] 0 0
Romania
State/province [32] 0 0
Cluj-Napoca
Country [33] 0 0
Romania
State/province [33] 0 0
Iasi
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
L'Hospitalet de Llobregat
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Palma de Mallorca
Country [38] 0 0
Spain
State/province [38] 0 0
Valencia
Country [39] 0 0
United Kingdom
State/province [39] 0 0
England
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Harrow
Country [41] 0 0
United Kingdom
State/province [41] 0 0
London

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 establish a safe and effective dosing regimen of
idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no
other therapeutic options.
Trial website
https://clinicaltrials.gov/show/NCT02536300
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
Other publications