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Dose Optimization Study of Idelalisib in Follicular Lymphoma | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Dose Optimization Study of Idelalisib in Follicular Lymphoma

NCT02536300•Gilead Sciences

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (66)

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

Key Dates

Start Date

January 14, 2016

Primary Completion Date

September 27, 2022

Completion Date

September 27, 2022

Last Updated

August 14, 2023

Enrollment

ACTUAL participants

Conditions

Follicular Lymphoma

Interventions

Idelalisib

DRUG

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

NCT06337318

Classic Follicular LymphomaFollicular Lymphoma With Unusual Cytological Features

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RECRUITINGPHASE1/PHASE2

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dose Optimization Study of Idelalisib in Follicular Lymphoma

Inclusion Criteria

Exclusion Criteria

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