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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02536300
Ethics application status
Date submitted
27/08/2015
Date registered
31/08/2015

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 BID - 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 BID - 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 BID INT - 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)
Timepoint [1] 0 0
Randomization up to end of treatment (maximum duration: 73.5 months)
Primary outcome [2] 0 0
Number of Participants With Grade 4 or Higher Treatment-Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
From first documentation of CR or PR until PD or death from any cause (maximum duration: 73.5 months)
Secondary outcome [2] 0 0
Overall Response Rate (ORR) by Week 24
Timepoint [2] 0 0
First dose date up to Week 24
Secondary outcome [3] 0 0
Number of Participants With Any TEAE, Grade 3 or Higher TEAEs, Serious TEAEs, Idelalisib-related TEAEs, TEAEs Leading to Interruption or Discontinuation of Idelalisib
Timepoint [3] 0 0
First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Secondary outcome [4] 0 0
Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities
Timepoint [4] 0 0
First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Secondary outcome [5] 0 0
Time to Onset of Adverse Events of Interest (AEIs)
Timepoint [5] 0 0
First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Secondary outcome [6] 0 0
Progression-Free Survival (PFS)
Timepoint [6] 0 0
Randomization up to PD or death from any cause (maximum duration: 73.5 months)
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
Randomization up to death from any cause (maximum duration: 73.5 months)
Secondary outcome [8] 0 0
Trough Plasma Concentration of Idelalisib
Timepoint [8] 0 0
Predose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 48
Secondary outcome [9] 0 0
Peak Plasma Concentration of Idelalisib
Timepoint [9] 0 0
1.5 hours postdose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 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 World Health Organization (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 available therapeutic options. Note: Rituximab maintenance is not routinely considered a separate line of therapy when it is given as part of the prior rituximab-containing regimen given over a number of cycles followed by maintenance. Rituximab monotherapy may be considered a separate line of therapy when disease relapse occurs between the initiation of rituximab monotherapy and the preceding line of therapy. If there are any ambiguities about eligibility, the site should consult with the medical monitor.
* 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
Sex
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 specifically CMV antiviral prophylaxis within 28 days prior to the screening visits 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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/09/2022
Sample size
Target
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Calvary Norht Adelaide Hosptial - Woodville South
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Barrie
Country [2] 0 0
Czechia
State/province [2] 0 0
Brno
Country [3] 0 0
Czechia
State/province [3] 0 0
Prague 10
Country [4] 0 0
Czechia
State/province [4] 0 0
Praha 5
Country [5] 0 0
France
State/province [5] 0 0
Avignon
Country [6] 0 0
France
State/province [6] 0 0
Bordeaux
Country [7] 0 0
France
State/province [7] 0 0
Le Mans
Country [8] 0 0
France
State/province [8] 0 0
Paris Cedex 10
Country [9] 0 0
France
State/province [9] 0 0
Paris cedex 12
Country [10] 0 0
France
State/province [10] 0 0
Poitiers Cedex
Country [11] 0 0
France
State/province [11] 0 0
Tours Cedex
Country [12] 0 0
France
State/province [12] 0 0
Vandoeuvre-lés-Nancy
Country [13] 0 0
Israel
State/province [13] 0 0
Haifa
Country [14] 0 0
Israel
State/province [14] 0 0
Kfar Saba
Country [15] 0 0
Italy
State/province [15] 0 0
Bergamo
Country [16] 0 0
Italy
State/province [16] 0 0
Brescia
Country [17] 0 0
Italy
State/province [17] 0 0
Genoa
Country [18] 0 0
Italy
State/province [18] 0 0
Genova
Country [19] 0 0
Italy
State/province [19] 0 0
Lecce
Country [20] 0 0
Italy
State/province [20] 0 0
Meldola
Country [21] 0 0
Italy
State/province [21] 0 0
Milano
Country [22] 0 0
Italy
State/province [22] 0 0
Orbassano
Country [23] 0 0
Italy
State/province [23] 0 0
Palermo
Country [24] 0 0
Italy
State/province [24] 0 0
Ravenna
Country [25] 0 0
Italy
State/province [25] 0 0
Rimini
Country [26] 0 0
Italy
State/province [26] 0 0
Rome
Country [27] 0 0
Italy
State/province [27] 0 0
Torino
Country [28] 0 0
Italy
State/province [28] 0 0
Udine
Country [29] 0 0
Poland
State/province [29] 0 0
Gdynia
Country [30] 0 0
Poland
State/province [30] 0 0
Katowice
Country [31] 0 0
Poland
State/province [31] 0 0
Kraków
Country [32] 0 0
Poland
State/province [32] 0 0
Legnica
Country [33] 0 0
Poland
State/province [33] 0 0
Lublin
Country [34] 0 0
Poland
State/province [34] 0 0
Opole
Country [35] 0 0
Poland
State/province [35] 0 0
Warszawa
Country [36] 0 0
Poland
State/province [36] 0 0
Wroclaw
Country [37] 0 0
Romania
State/province [37] 0 0
Baia Mare
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Burgos
Country [40] 0 0
Spain
State/province [40] 0 0
Cáceres
Country [41] 0 0
Spain
State/province [41] 0 0
L'Hospitalet de Llobregat
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Spain
State/province [43] 0 0
Majadahonda
Country [44] 0 0
Spain
State/province [44] 0 0
Murcia
Country [45] 0 0
Spain
State/province [45] 0 0
Palma de Mallorca
Country [46] 0 0
Spain
State/province [46] 0 0
Santa Cruz de Tenerife
Country [47] 0 0
Spain
State/province [47] 0 0
Santander
Country [48] 0 0
Spain
State/province [48] 0 0
Terrassa
Country [49] 0 0
Spain
State/province [49] 0 0
Valencia
Country [50] 0 0
Spain
State/province [50] 0 0
Zaragoza
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Canterbury
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Harrow
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Liverpool
Country [54] 0 0
United Kingdom
State/province [54] 0 0
London
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Oldham
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Torquay

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 https://www.gileadclinicaltrials.com/transparency-policy/

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: https://www.gileadclinicaltrials.com/transparency-policy/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02536300