TerminatedPhase 4

Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820

Netherlands3 participantsStarted 2016-05-04

Plain-language summary

The primary objective of this study is to provide idelalisib to participants receiving GS-9820 in Gilead-sponsored Study GS-US-315-0102 at the time of study closure.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Receiving GS-9820 in Study GS-US-315-0102 with objective evidence of clinical benefit * Evidence of a personally signed informed consent Key Exclusion Criteria: * Known hypersensitivity or intolerance to any of the active substances or excipients in the formulation of idelalisib * Toxicities that would preclude initiating therapy with idelalisib prior to enrollment * Concurrent participation in another therapeutic clinical trial * Ongoing infection, treatment, or prophylaxis for cytomegalovirus (CMV) within the past 28 days. Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths

Timeframe: Up to Day 602 plus 30 days

Trial details

NCT IDNCT02739360

SponsorGilead Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12-28

Results submitted2018-12-17

View on ClinicalTrials.gov More Lymphoid Malignancies trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.