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Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas
NCT01282424 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety.
Conditions Studied
Interventions
- DRUG Idelalisib
Study Locations (20)
California
- St. Jude Medical Center — Fullerton
- Pacific Shores Medical Group — Long Beach
- UCLA — Los Angeles
- Central Coast Medical Oncology — Santa Maria
- Stanford Cancer Center — Stanford
New Jersey
- John Theurer Cancer Center Hackensack University Medical Center — Hackensack
- University of Medicine and Dentistry of NJ — New Brunswick
New York
- Weill Cornell -New York Presbyterian Hospital — New York
- Montefiore Medical Center — New York
Tennessee
- Chattanooga Hem/Oncology Ass (SCRI) — Chattanooga
- Sarah Cannon Research Institute — Nashville
Florida
- Collaborative Research Group, LLC — Boynton Beach
Georgia
- Winship Cancer Institute — Atlanta
Illinois
- Northwestern University Robert H. Lurie Comprehensive Cancer Center — Chicago
Missouri
- Washington University School of Medicine — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2011-03-18 |
| Est. Completion | 2018-05-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01282424
The ClinicalTrials.gov registry entry for NCT01282424 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Follicular Lymphoma appearing as the primary indexed condition, and to 1 intervention — of which Idelalisib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01282424 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, New Jersey, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01282424 about?
NCT01282424 is a clinical study titled "Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas". The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. ...
What is the current status of trial NCT01282424?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2011-03-18. Estimated completion is 2018-05-16.
What conditions does trial NCT01282424 study?
This clinical trial studies the following conditions: Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma, Lymphoplasmacytic Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01282424?
The interventions under investigation include: Idelalisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01282424?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01282424 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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