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NCT01282424 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas
A Phase 2 study of Follicular Lymphoma and Small Lymphocytic Lymphoma, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
- 20
- Study locations
NCT01282424: Completed Phase 2 study of Follicular Lymphoma and Small Lymphocytic Lymphoma, sponsored by Gilead Sciences.
NCT01282424 is a Phase 2 study of Follicular Lymphoma and Small Lymphocytic Lymphoma that has completed, run by Gilead Sciences. The registered enrollment target is 125 participants, roughly in line with the 134-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01282424, a Phase 2 study of Follicular Lymphoma and Small Lymphocytic Lymphoma, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) or partial response (PR; or minor response \[MR\] for participants with WM) as assessed by the study independent review committee (IRC). CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and
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 |
What the finished NCT01282424 record still lists
NCT01282424 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 134-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target.
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.
NCT01282424 names 20 study sites across 13 states, led by California, New Jersey, New York.
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.
What interventions are being tested in trial NCT01282424?
The interventions under investigation include: Idelalisib (DRUG).
Who is sponsoring clinical trial NCT01282424?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01282424's enrollment target sits among peer trials
125 27th of 89 higher than 63 of 89 other Follicular Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Follicular Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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