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Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma (ZEUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03568929
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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

Condition or disease Intervention/treatment
Follicular Non-Hodgkin's Lymphoma Refractory Drug: Idelalisib

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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Non-interventional Study to Assess the Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma (FL)
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Idelalisib

Group/Cohort Intervention/treatment
Idelalisib
Participants who have been or are currently being treated with 100 or 150 mg of idelalisib
Drug: Idelalisib
Tablets administered according to the product information and treatment guidelines in routine clinical practice
Other Name: Zydelig®




Primary Outcome Measures :
  1. 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: 300 patient-years (8 months of treatment period, 3 years of retrospective time frame, and 2.5 years of prospective observation period) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals who were or are being treated with idelalisib for refractory FL according to the product information and treatment guidelines in routine clinical practice after the country specific approval date.
Criteria

Inclusion Criteria:

  • Individuals who were or are being treated for refractory 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568929


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03568929     History of Changes
Other Study ID Numbers: GS-EU-313-4172
EUPAS19618 ( Other Identifier: ENCePP )
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Idelalisib
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action