Follicular LymphomaPhase 3NCT02536300
Dose Optimization Study of Idelalisib in Follicular Lymphoma
A Phase 3 study testing Idelalisib in people with Follicular Lymphoma, run by Gilead Sciences at 66 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Idelalisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 66 sitesin 10 countries
- Study dates
- 14 Jan 2016to 27 Sep 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
66 sites in 10 countries.
66 sites in 10 countries
Spain17 sites
Hospital del Mar
Barcelona, 08003
Hospital Universitario de Burgos
Burgos, 09006
Hospital San Pedro de Alcantara
Cáceres, 10003
Institut Catala d'Oncologia Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08908
Hospital General Universiario Gregorio Maranon
Madrid, 28009
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Universitario Ramon y Cajal
Madrid, 28034
Fundacion Jimenez Diaz
Madrid, 28040
Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, 28050
Hospital Puerta de Hierro Majadahonda
Majadahonda, 28222
Hospital Genereal Universitario Morales Meseguer
Murcia, 30008
Hospital Son Llatzer
Palma de Mallorca, 07198
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320
Hospital Universitario Marques de Valdecilla
Santander, 39008
Hospital Universitario Mutua Terrassa
Terrassa, 08221
CEIm-Regional De La Comunidad De Madrid
Valencia, 46026
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Italy16 sites
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
ASST Spedali Civili
Brescia, 25123
Ospedale Policlinico San Martino IRCCS-Clinica Ematologica
Genoa, 16132
Azienda Policlinico San Martino
Genova, 16132
Azienda Ospedaliera Cardinale G Panico di Tricase-Unita Operativa Complessa di Ematologia e TMO
Lecce, 73039
Azienda Ospedaliera Vito Fazzi Unita Operativa di Ematologia
Lecce, 73100
Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Dipartimento di Oncologia Medica
Meldola, 47014
IRCCS Ospendale San Raffaele
Milan, 20132
SCDU Ematologia e Terapie Cellulari Azienda Ospedaliera Ordine Mauriziano di Torino
Orbassano, 10043
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
Palermo, 90146
Azienda Unita Sanitaria Locale di Ravenna, U.O di Ematologia
Ravenna, 48121
Ospedale degli Infermi-Oncoematologia
Rimini, 47900
Fondazione Policlinico Tor Vergata-UOC Patologie Linfoproliferative
Rome, 00133
Ospedale S. Eugenio
Rome, 00144
Dipartimento di Ematologia ed Oncoematolgia - S.C Ematolgia
Torino, 10126
A.S.U. Integrata Santa Maria della Misericordia
Udine, 33100
Poland9 sites
Szpitale Wojewodzkie w Gdyni Sp. z o.o.
Gdynia, 81-519
PRATIA Onkologia Katowice
Katowice, 40-519
Malopolskie Centrum Medyczne
Krakow, 30-510
Wojewodzki Szpital Specjalistyczny w Legniicy
Legnica, 59-220
Gabinety Lekarskie Hema
Lublin, 20-090
Szpital Wojewodzki w Opolu Sp. z o.o.
Opole, 45-372
Instytut Hematologii i Transfuzjologii, Klinika Hematologii
Warsaw, 02-776
Centrum Onkologii Instytut im.Marii Sklodowskiej Curie
Warsaw, 02-781
Klinika Hematologii Nowotworow Kriwi i Transplantacji Szpiku
Wroclaw, 50-367
France8 sites
Centre Hospitalier d'Avignon-Hopital Henri Duffaut
Avignon, 84000
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33077
Centre Hospitalier Le Mans
Le Mans, 72037
Hopital Saint Antoine
Paris, 72012
Hopital Saint Louis
Paris, 75475
Centre Hospitalier Universaitaire de Poit iers-Pole Regional de Cancerlogie
Poitiers, 86021
Centre Hospitalier de Tours-Hopital Bretoneau Centre Regional de Cancerologie Henry Kaplan
Tours, 37044
Clinique Louis Pasteur
Vandoeuvre-lés-Nancy, 54511
United Kingdom8 sites
East Kent Hospitals University NHS Foundation Trust
Canterbury, CT1 3NG
London North West University Healthcare NHS Trust
Harrow, HA1 3UJ
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, L7 8XP
Barts Health Trust
London, EC1A7BE
University College London Hospitals NHS Foundation Trust
London, NW1 2PG
St George's Hospital NHS Trust
London, SW17 0QT
The Pennine Acute Hospital NHS Trust
Oldham, OL1 2JH
Torbay and South Devon NHS Foundation Trust
Torquay, TQ2 7AA
Czechia3 sites
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika
Brno, 625 00
Fakultni nemocnice Kralovske Vinohrady
Prague, 10034
Fakulni newmcince v Motole, Onkologicka klinika 2. LF UK a FN Motol
Prague, 150 06
Israel2 sites
Carmel Medical Center
Haifa, 34362
Meir Medical Center
Kfar Saba, 4428164
Australia1 site
Calvary Norht Adelaide Hosptial
Woodville South, South Australia, 5011
Romania1 site
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
Baia Mare, 430031
About this study
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.
- Conditions
- Follicular Lymphoma
- Being tested
- Idelalisib
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdelalisibDrug
Also called Zydelig®, GS-1101, CAL-101
Idelalisib tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Idelalisib 150 mg BID | Experimental | 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. Receives: Drug: Idelalisib |
| Idelalisib 100 mg BID | Experimental | 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. Receives: Drug: Idelalisib |
| Idelalisib 150 mg BID INT | Experimental | Participants will receive idelalisib 150 mg twice daily in 28-day cycles with 21 days on-treatment and 7 days off-treatment. Receives: Drug: Idelalisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR was defined as percentage of participants who achieve a partial response (PR) or complete response (CR). PR criteria: No evidence of new disease, a ≥50% decrease from baseline in sum of products of diameters (SPD) of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. Persistence of bone marrow involvement in a participant who meets other criteria for CR based on the disappearance of all nodal and extra-nodal masses. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in longest dimension (LD) for large nodes and ≤1.0 cm in LD, ≤1.0 cm in longest perpendicular dimension (LPD) for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow.
Measured: Randomization up to end of treatment (maximum duration: 73.5 months)
Number of Participants With Grade 4 or Higher Treatment-Emergent Adverse Events (TEAEs)
TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. TEAEs severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants were counted at the highest AE grade experienced.
Measured: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Secondary outcomes (9)
Duration of Response (DOR)
DOR: interval from first documentation of CR/PR to earlier of first documentation of disease progression (PD) by independent review committee (IRC)/death from any cause. PR:No evidence of new disease,≥50% decrease from baseline in SPD of index lesions,no increase in non-index disease, no increase in liver/spleen size,no new liver/spleen enlargement; Persistence of bone marrow involvement in participant who meets other CR criteria. CR: No evidence of new disease,regression of all index nodal lesions to normal size (large nodes:≤1.5 cm in LD;small nodes:≤1.0 cm in LD,≤1.0 cm in LPD), regression to normal of all nodal non-index disease,disappearance of all detectable extra-nodal index,non-index disease,normal spleen and liver size, no new liver/spleen enlargement; PD: New node of >1.5 cm or >1.0 to ≤1.5 cm in LD, >1.0 cm in LPD, new/unequivocal reappearance of resolved extra-nodal lesion,new non-index disease,increase by 50% in SPD of index lesions,LD of individual node/extra-nodal mass.
Measured: From first documentation of CR or PR until PD or death from any cause (maximum duration: 73.5 months)
Overall Response Rate (ORR) by Week 24
ORR by Week 24 is defined as the percentage of participants who achieve a PR or CR by Week 24.
PR criteria: No evidence of new disease, a 50% decrease from baseline in SPD of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in LD for large nodes and ≤1.0 cm in LD, ≤1.0 cm in LPD for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow.
Measured: First dose date up to Week 24
Number of Participants With Any TEAE, Grade 3 or Higher TEAEs, Serious TEAEs, Idelalisib-related TEAEs, TEAEs Leading to Interruption or Discontinuation of Idelalisib
TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. TEAEs severity was graded according to the NCI CTCAE version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants are counted at the highest AE grade experienced.
Measured: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days. Laboratory abnormalities included hematology and serum chemistry parameters. Clinically significant laboratory abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for severity as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening). The number of participants with any post-baseline abnormal laboratory value in Grade 1-4 categories are reported.
Measured: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Time to Onset of Adverse Events of Interest (AEIs)
Time to onset of AEIs is defined as the interval (in months) from the start of idelalisib treatment to the first documentation of start of AEI. AEIs included grade ≥ 3 diarrhea/colitis, rash, febrile neutropenia, infection, and any grade of: Pneumonitis, bowel perforation, progressive multifocal leukoencephalopathy (PML), Pneumocystis jirovecii pneumonia (PJP), cytomegalovirus (CMV) infection, and organizing pneumonia.
Measured: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Progression-Free Survival (PFS)
PFS is defined as the interval (in months) from randomization to the earlier of the first documentation of PD by IRC or death from any cause. PD criteria: New node of >1.5 cm or >1.0 cm to ≤1.5 cm in LD, >1.0 cm in LPD, new/unequivocal reappearance of resolved extra-nodal lesion, new non-index disease, increase by 50% in SPD of index lesions, LD of individual node/extra-nodal mass.
Measured: Randomization up to PD or death from any cause (maximum duration: 73.5 months)
Overall Survival (OS)
OS is defined as the interval (in months) from randomization to death from any cause.
Measured: Randomization up to death from any cause (maximum duration: 73.5 months)
Trough Plasma Concentration of Idelalisib
Measured: Predose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 48
Peak Plasma Concentration of Idelalisib
Measured: 1.5 hours postdose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study start14 Jan 2016
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
Why it stopped: Gilead has made the decision to close the study due to enrollment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- As of protocol amendment 5, the Idelalisib 100 mg arm is closed to enrollment.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536300
- Sponsor's protocol ID
- GS-US-313-1580
- Other IDs
- 2015-000366-66, 2015
- Status last verified
- Aug 2023
- First submitted
- 27 Aug 2015
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Optimization Study of Idelalisib in Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT02536300
- Acronym / sponsor ID
- GS-US-313-1580
- Conditions
- Follicular Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Gilead has made the decision to close the study due to enrollment challenges
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- As of protocol amendment 5, the Idelalisib 100 mg arm is closed to enrollment.
| Arm | Type | Receives |
|---|---|---|
| Idelalisib 150 mg BID | Experimental | Drug: IdelalisibParticipants 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. |
| Idelalisib 100 mg BID | Experimental | Drug: IdelalisibParticipants 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. |
| Idelalisib 150 mg BID INT | Experimental | Drug: IdelalisibParticipants will receive idelalisib 150 mg twice daily in 28-day cycles with 21 days on-treatment and 7 days off-treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IdelalisibAlso: Zydelig®, GS-1101, CAL-101Idelalisib tablet administered orally | Drug | Idelalisib 100 mg BID, Idelalisib 150 mg BID, Idelalisib 150 mg BID INT |
Primary outcome
Overall Response Rate (ORR)
Time frame: Randomization up to end of treatment (maximum duration: 73.5 months)
ORR was defined as percentage of participants who achieve a partial response (PR) or complete response (CR). PR criteria: No evidence of new disease, a ≥50% decrease from baseline in sum of products of diameters (SPD) of index lesions, no increase in non-index disease, no increase in liver/spleen size and no new liver/spleen enlargement. Persistence of bone marrow involvement in a participant who meets other criteria for CR based on the disappearance of all nodal and extra-nodal masses. CR criteria: No evidence of new disease, regression of all index nodal lesions to normal size (≤1.5 cm in longest dimension (LD) for large nodes and ≤1.0 cm in LD, ≤1.0 cm in longest perpendicular dimension (LPD) for small nodes), regression to normal of all nodal non-index disease, disappearance of all detectable extra-nodal index and non-index disease, normal spleen and liver size, no new liver/spleen enlargement, morphologically negative bone marrow.
Number of Participants With Grade 4 or Higher Treatment-Emergent Adverse Events (TEAEs)
Time frame: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. TEAEs severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants were counted at the highest AE grade experienced.
9 secondary outcomes
Duration of Response (DOR)
Time frame: From first documentation of CR or PR until PD or death from any cause (maximum duration: 73.5 months)
Overall Response Rate (ORR) by Week 24
Time frame: First dose date up to Week 24
Number of Participants With Any TEAE, Grade 3 or Higher TEAEs, Serious TEAEs, Idelalisib-related TEAEs, TEAEs Leading to Interruption or Discontinuation of Idelalisib
Time frame: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Number of Participants With Clinically Significant Treatment-Emergent Laboratory Abnormalities
Time frame: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Time to Onset of Adverse Events of Interest (AEIs)
Time frame: First dose date up to 30 days after last dose of study drug (maximum 64.6 months)
Progression-Free Survival (PFS)
Time frame: Randomization up to PD or death from any cause (maximum duration: 73.5 months)
Overall Survival (OS)
Time frame: Randomization up to death from any cause (maximum duration: 73.5 months)
Trough Plasma Concentration of Idelalisib
Time frame: Predose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 48
Peak Plasma Concentration of Idelalisib
Time frame: 1.5 hours postdose on Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
66 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Idelalisib in people with Follicular Lymphoma, run by Gilead Sciences at 66 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Spain, Italy, Poland, France, United Kingdom and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Randomization up to end of treatment (maximum duration: 73.5 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.