Dose Optimization Study of Idelalisib in Follicular Lymphoma

NCT ID: NCT02536300

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-14
• Study Completion Date: 2022-09-27

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.

Conditions

Follicular Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Idelalisib

Intervention Type: DRUG

Idelalisib tablet administered orally

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.

Group Type: EXPERIMENTAL

Idelalisib

Intervention Type: DRUG

Idelalisib tablet administered orally

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.

Group Type: EXPERIMENTAL

Idelalisib

Intervention Type: DRUG

Idelalisib tablet administered orally

Interventions

Idelalisib

Idelalisib tablet administered orally

Intervention Type: DRUG

Other Intervention Names

Zydelig®; GS-1101; CAL-101

Eligibility Criteria

Inclusion Criteria

• 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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Calvary Norht Adelaide Hosptial

Woodville South, South Australia, Australia

Royal Victoria Regional Health Centre

Barrie, , Canada

Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

Brno, , Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Fakulni newmcince v Motole, Onkologicka klinika 2. LF UK a FN Motol

Prague, , Czechia

Centre Hospitalier d'Avignon-Hopital Henri Duffaut

Avignon, , France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, , France

Centre Hospitalier Le Mans

Le Mans, , France

Hopital Saint Antoine

Paris, , France

Hopital Saint Louis

Paris, , France

Centre Hospitalier Universaitaire de Poit iers-Pole Regional de Cancerlogie

Poitiers, , France

Centre Hospitalier de Tours-Hopital Bretoneau Centre Regional de Cancerologie Henry Kaplan

Tours, , France

Clinique Louis Pasteur

Vandoeuvre-lés-Nancy, , France

Carmel Medical Center

Haifa, , Israel

Meir Medical Center

Kfar Saba, , Israel

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, , Italy

ASST Spedali Civili

Brescia, , Italy

Ospedale Policlinico San Martino IRCCS-Clinica Ematologica

Genoa, , Italy

Azienda Policlinico San Martino

Genova, , Italy

Azienda Ospedaliera Cardinale G Panico di Tricase-Unita Operativa Complessa di Ematologia e TMO

Lecce, , Italy

Azienda Ospedaliera Vito Fazzi Unita Operativa di Ematologia

Lecce, , Italy

Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Dipartimento di Oncologia Medica

Meldola, , Italy

IRCCS Ospendale San Raffaele

Milan, , Italy

SCDU Ematologia e Terapie Cellulari Azienda Ospedaliera Ordine Mauriziano di Torino

Orbassano, , Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

Palermo, , Italy

Azienda Unita Sanitaria Locale di Ravenna, U.O di Ematologia

Ravenna, , Italy

Ospedale degli Infermi-Oncoematologia

Rimini, , Italy

Fondazione Policlinico Tor Vergata-UOC Patologie Linfoproliferative

Rome, , Italy

Ospedale S. Eugenio

Rome, , Italy

Dipartimento di Ematologia ed Oncoematolgia - S.C Ematolgia

Torino, , Italy

A.S.U. Integrata Santa Maria della Misericordia

Udine, , Italy

Szpitale Wojewodzkie w Gdyni Sp. z o.o.

Gdynia, , Poland

PRATIA Onkologia Katowice

Katowice, , Poland

Malopolskie Centrum Medyczne

Krakow, , Poland

Wojewodzki Szpital Specjalistyczny w Legniicy

Legnica, , Poland

Gabinety Lekarskie Hema

Lublin, , Poland

Szpital Wojewodzki w Opolu Sp. z o.o.

Opole, , Poland

Instytut Hematologii i Transfuzjologii, Klinika Hematologii

Warsaw, , Poland

Centrum Onkologii Instytut im.Marii Sklodowskiej Curie

Warsaw, , Poland

Klinika Hematologii Nowotworow Kriwi i Transplantacji Szpiku

Wroclaw, , Poland

Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare

Baia Mare, , Romania

Hospital del Mar

Barcelona, , Spain

Hospital Universitario de Burgos

Burgos, , Spain

Hospital San Pedro de Alcantara

Cáceres, , Spain

Institut Catala d'Oncologia Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, , Spain

Hospital General Universiario Gregorio Maranon

Madrid, , Spain

Hospital Universitario Infanta Leonor

Madrid, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Fundacion Jimenez Diaz

Madrid, , Spain

Centro Integral Oncologico Clara Campal (CIOCC)

Madrid, , Spain

Hospital Puerta de Hierro Majadahonda

Majadahonda, , Spain

Hospital Genereal Universitario Morales Meseguer

Murcia, , Spain

Hospital Son Llatzer

Palma de Mallorca, , Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, , Spain

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Hospital Universitario Mutua Terrassa

Terrassa, , Spain

CEIm-Regional De La Comunidad De Madrid

Valencia, , Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, , Spain

East Kent Hospitals University NHS Foundation Trust

Canterbury, , United Kingdom

London North West University Healthcare NHS Trust

Harrow, , United Kingdom

Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, , United Kingdom

Barts Health Trust

London, , United Kingdom

University College London Hospitals NHS Foundation Trust

London, , United Kingdom

St George's Hospital NHS Trust

London, , United Kingdom

The Pennine Acute Hospital NHS Trust

Oldham, , United Kingdom

Torbay and South Devon NHS Foundation Trust

Torquay, , United Kingdom

Countries

Australia; Canada; Czechia; France; Israel; Italy; Poland; Romania; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.gileadclinicaltrials.com/study/?id=GS-US-313-1580

Gilead Clinical Trials Website

Other Identifiers

2015-000366-66

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-313-1580

Identifier Type: -

Identifier Source: org_study_id