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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 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.

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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.

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

FieldValue
Enrollment Target 125 participants
Start Date 2011-03-18
Est. Completion 2018-05-16
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT01282424

The ClinicalTrials.gov registry entry for NCT01282424 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 134-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.