Completed

NCT Number: NCT03568929

Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma

The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL).

Completed

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Key information

Conditions

Follicular Non-Hodgkin's Lymphoma Refractory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Netwerk Antwerpen Stuivenberg Hospital, Antwerp, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals who were or are being treated for refractory Follicular Lymphoma (FL) according to the product information for idelalisib and treatment guidelines in routine clinical practice.

Exclusion criteria

Individuals included in clinical trials on idelalisib within the timeframe of this study.

Treatment and study plan

idelalisib

Drug

Tablets administered according to the product information and treatment guidelines in routine clinical practice

Other names: Zydelig®

Primary outcomes

Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AE), Serious AEs, Special Situation Reports, Adverse Drug Reactions (ADR), and Serious ADRs

Time frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)

Secondary outcomes

Overall Response Rate (ORR)

Time frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)

ORR is defined as the proportion of participants who achieve a clinical response with or without radiological confirmation as documented within their electronic health record after the initiation of treatment with idelalisib and during the treatment period with idelalisib.
Duration of Response (DOR)

Time frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)

DOR is defined as the interval from the first documentation of a clinical response with or without radiological confirmation to the earlier of the first documentation of disease progression or death from any cause.
Progression-free Survival (PFS)

Time frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)

PFS is defined as the interval from the date of initiation of idelalisib to the earlier date of the first documentation of disease progression or death from any cause.
Time to Next Treatment (TTNT)

Time frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)

TTNT is defined as the interval from the initiation of treatment with idelalisib to the earlier date of the initiation of next systemic treatment of Follicular Lymphoma (excluding palliative care or palliative radiation) or death from any cause.
Overall Survival (OS)

Time frame: 250 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period)

OS is defined as the interval from the date of initiation of idelalisib to death from any cause.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

Non-interventional Study to Assess the Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma (FL)

Acronym: ZEUS

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Jun 26, 2018
Registry last updated: Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.